← Product Code BWK · K244030

# Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) (K244030)

_Wuxi Jiajian Medical Instrument Co., Ltd. · BWK · Mar 28, 2025 · NE · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K244030

## Device Facts

- **Applicant:** Wuxi Jiajian Medical Instrument Co., Ltd.
- **Product Code:** BWK
- **Decision Date:** Mar 28, 2025
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** NE
- **Attributes:** Therapeutic

## Intended Use

Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

## Device Story

Needle Stimulator (models CMNS6-1 PLUS, CMNS6-3) is an electro-acupuncture device used by qualified acupuncture practitioners in clinical settings. The device console connects to 6 channels via electrode cables with alligator connectors; it does not include needles. Powered by batteries or AC, the device delivers electrical stimulation to acupuncture needles placed by the practitioner. It features three output modes (continuous, interrupted, dense-disperse) and uses voltage-controlled, biphasic, asymmetric square wave pulses. The practitioner operates the device via function knobs/buttons to adjust stimulation parameters. The output is intended to provide acupuncture therapy. The device incorporates microprocessor control to manage stimulation delivery and safety features, including user override and automatic shut-off. By providing controlled electrical stimulation, the device assists practitioners in acupuncture therapy, potentially benefiting patients through the intended therapeutic effects of electro-acupuncture.

## Clinical Evidence

No clinical data included. Substantial equivalence is supported by bench testing, including electrical safety (ANSI/AAMI ES60601-1) and electromagnetic compatibility (IEC 60601-1-2, IEC TS 60601-4-2).

## Technological Characteristics

Electro-acupuncture stimulator; voltage-controlled; biphasic asymmetric square wave output. 6 channels; transformer isolation; Type BF patient contact. Powered by 6x 1.5V batteries or 100-240V AC. Housing: ABS plastic (injection molded). Biocompatibility: ISO 10993-5, ISO 10993-10. Connectivity: None (standalone). Sterilization: Not applicable (device does not include needles). Software: Microprocessor-controlled.

## Predicate Devices

- Needle Stimulator ([K202861](/device/K202861.md))

## Submission Summary (Full Text)

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March 28, 2025

Wuxi Jiajian Medical Instrument Co., Ltd. % Doris Dong Official Correspondent Shanghai CV Technology Co., Ltd. Room 805, No.19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China

Re: K244030

Trade/Device Name: Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) Regulatory Class: Unclassified Product Code: BWK Dated: December 2, 2024 Received: December 30, 2024

Dear Doris Dong:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

# Amber T. Ballard -S

Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K244030

Device Name Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)

Indications for Use (Describe)

Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary [As required by 21 CFR 807.92]

#### 1. Submission Information:

| 510(k) Number:               | K244030                                                                                                                                                                                                                        |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date:                        | March 24, 2025                                                                                                                                                                                                                 |
| Type of 510(k) Submission:   | Traditional                                                                                                                                                                                                                    |
| Basis for 510(k) Submission: | New device                                                                                                                                                                                                                     |
| Submitter/Manufacturer:      | Wuxi Jiajian Medical Instrument Co., Ltd<br>No. 35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi,<br>Jiangsu, China 214116                                                                                                      |
| Contact:                     | Doris Dong<br>[Consultant, from Shanghai CV Technology Co., Ltd.]<br>Add: Room 805, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613<br>China<br>E-mail: doris.d@ceve.org.cn<br>Tel: 86 21-31261348 / Fax: 86 21-57712250 |

#### 2. Device Description:

| Proprietary Name:    | Needle Stimulator                                                                                                                                                                                                                                                                                                                                                                                                                 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model:               | CMNS6-1 PLUS, CMNS6-3                                                                                                                                                                                                                                                                                                                                                                                                             |
| Common Name:         | Electro-Acupuncture                                                                                                                                                                                                                                                                                                                                                                                                               |
| Classification Name: | Stimulator, Electro-Acupuncture                                                                                                                                                                                                                                                                                                                                                                                                   |
| Product Code:        | BWK                                                                                                                                                                                                                                                                                                                                                                                                                               |
| Device Class:        | Unclassified                                                                                                                                                                                                                                                                                                                                                                                                                      |
| Review Panel:        | Neurology                                                                                                                                                                                                                                                                                                                                                                                                                         |
| Device Description:  | Needle Stimulator is an electro-acupuncture device for acupuncture therapy, powered by 6 pieces of 1.5V batteries or AC 100-240V. It is composed of a console and 6 channels of electrode cables with alligator type connectors. The console has the operating controls including function knobs or buttons. Needle Stimulator does not equip with acupuncture needles. The practitioners should select legally marketed needles. |
| Indications for use: | Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.                                                                                                                                                                                                                                   |

## 3. Predicate Device Identification

| Predicate 510(k) Number:  | K202861                                   |
|---------------------------|-------------------------------------------|
| Marketing Clearance Date: | 08/27/2021                                |
| Product Name:             | Needle Stimulator                         |
| Manufacturer:             | Wuxi Jiajian Medical Instrument Co., Ltd. |

#### 4. Substantial Equivalence to Predicate device:

Detailed comparison data is included in "Substantial Equivalence Discussion - CMNS6-1 PLUS" of this 510(k) submission.

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Table 1-

| Parameters | Subject Device                                                                                           | Predicate Device                                                                                                                                                                                                  | Remark                                                                                                                                                                                                            |                                               |                   |
|------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|-------------------|
| 1          | 510(k) Number:                                                                                           | K244030                                                                                                                                                                                                           | K202861                                                                                                                                                                                                           | --                                            |                   |
| 2          | Marketing clearance date:                                                                                | --                                                                                                                                                                                                                | 08/27/2021                                                                                                                                                                                                        | --                                            |                   |
| 3          | Device Name                                                                                              | Needle Stimulator                                                                                                                                                                                                 | Needle Stimulator                                                                                                                                                                                                 | --                                            |                   |
| 4          | Model                                                                                                    | CMNS6-1 PLUS                                                                                                                                                                                                      | CMNS6-1                                                                                                                                                                                                           | --                                            |                   |
| 5          | Manufacturer                                                                                             | Wuxi Jiajian Medical Instrument Co.,Ltd                                                                                                                                                                           | Wuxi Jiajian Medical Instrument Co.,Ltd                                                                                                                                                                           | Same                                          |                   |
| 6          | Indications for Use                                                                                      | Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.                   | Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.                   | Same                                          |                   |
| 7          | Type of use                                                                                              | Prescription use                                                                                                                                                                                                  | Prescription use                                                                                                                                                                                                  | Same                                          |                   |
| 8          | Power Source(s)                                                                                          | DC 1.5Vx6 Type R14 or AC 100-240V                                                                                                                                                                                 | DC 1.5Vx6 Type R14 or AC 100-240V                                                                                                                                                                                 | Same                                          |                   |
|            | Method of Line Current Isolation                                                                         | Type BF                                                                                                                                                                                                           | Type BF                                                                                                                                                                                                           | Same                                          |                   |
|            | Patient Leakage Current                                                                                  | --                                                                                                                                                                                                                | --                                                                                                                                                                                                                | Same                                          |                   |
|            | Normal Condition (μΑ)                                                                                    | 2μΑ                                                                                                                                                                                                               | 2μΑ                                                                                                                                                                                                               |                                               |                   |
|            | Single Fault Condition (μΑ)                                                                              | ≤50μΑ                                                                                                                                                                                                             | ≤50μΑ                                                                                                                                                                                                             |                                               |                   |
| 9          | Average DC current through electrodes when device is on but no pulses are being applied (µA)             | N/A                                                                                                                                                                                                               | N/A                                                                                                                                                                                                               | Same                                          |                   |
| 10         | Number of Output Modes                                                                                   | 3 (continuous wave/ interrupted wave/ Dense-disperse wave)                                                                                                                                                        | 3 (continuous wave/ interrupted wave/ Dense-disperse wave)                                                                                                                                                        | Same                                          |                   |
|            | Number of Output channels:                                                                               | 6 (3 channels at most work together on single patient)                                                                                                                                                            | 6 (3 channels at most work together on single patient)                                                                                                                                                            | Same                                          |                   |
| 11         | Synchronous or Alternating?                                                                              | Synchronous                                                                                                                                                                                                       | Synchronous                                                                                                                                                                                                       | Same                                          |                   |
|            | Method of Channel Isolation                                                                              | Transformer                                                                                                                                                                                                       | Transformer                                                                                                                                                                                                       | Same                                          |                   |
| 12         | Regulated Current or Regulated Voltage?                                                                  | Voltage Control                                                                                                                                                                                                   | Voltage Control                                                                                                                                                                                                   | Same                                          |                   |
| 13         | Software/Firmware/Microprocessor                                                                         | Yes                                                                                                                                                                                                               | Yes                                                                                                                                                                                                               | Same                                          |                   |
| 14         | Automatic Overload<br>Trip?                                                                              |                                                                                                                                                                                                                   | No                                                                                                                                                                                                                | No                                            | Same              |
| 15         | Automatic No-Load<br>Trip?                                                                               |                                                                                                                                                                                                                   | Yes                                                                                                                                                                                                               | No                                            | Similar<br>Note 1 |
| 16         | Automatic Shut Off?                                                                                      |                                                                                                                                                                                                                   | Yes                                                                                                                                                                                                               | Yes                                           | Same              |
| 17         | User<br>Override<br>Control?                                                                             |                                                                                                                                                                                                                   | Yes                                                                                                                                                                                                               | Yes                                           | Same              |
|            | Indicator<br>Display:                                                                                    | On/Off<br>Status?                                                                                                                                                                                                 | Yes                                                                                                                                                                                                               | Yes                                           | Same              |
| 18         |                                                                                                          | Low<br>Battery?                                                                                                                                                                                                   | No                                                                                                                                                                                                                | Yes                                           | Similar<br>Note 1 |
|            |                                                                                                          | Voltage/<br>Current<br>Level?                                                                                                                                                                                     | No                                                                                                                                                                                                                | Yes                                           |                   |
| 19         | Timer<br>(minutes)                                                                                       | Range                                                                                                                                                                                                             | 1-60min                                                                                                                                                                                                           | 0-60min                                       | Similar<br>Note 3 |
| 20         | Compliance with<br>Voluntary Standards?                                                                  |                                                                                                                                                                                                                   | IEC 60601-1,IEC 60601-1-2                                                                                                                                                                                         | IEC 60601-1, IEC 60601-2-10,<br>IEC 60601-1-2 | Similar<br>Note 2 |
| 21         | Compliance with 21<br>CFR 898?                                                                           |                                                                                                                                                                                                                   | Yes                                                                                                                                                                                                               | Yes                                           | Same              |
| 22         | Weight (grams)                                                                                           |                                                                                                                                                                                                                   | 740g                                                                                                                                                                                                              | 740g                                          | Same              |
| 23         | Dimensions [W x H<br>x D]                                                                                |                                                                                                                                                                                                                   | 234*160*76mm                                                                                                                                                                                                      | 230*155*55mm                                  | Similar<br>Note 3 |
| 24         | Housing Materials &<br>Construction                                                                      |                                                                                                                                                                                                                   | ABS;Injection molded                                                                                                                                                                                              | ABS; Injection molded                         | Same              |
| 25         | Waveform                                                                                                 |                                                                                                                                                                                                                   | Biphasic                                                                                                                                                                                                          | Biphasic                                      | Same              |
| 26         | Shape                                                                                                    |                                                                                                                                                                                                                   | Asymmetric biphasic square<br>wave                                                                                                                                                                                | Asymmetric biphasic square<br>wave            | Same              |
|            | Maximum<br>Output<br>Voltage (volts)                                                                     |                                                                                                                                                                                                                   | 35V±20%@500Ω                                                                                                                                                                                                      | 27V±10% @500Ω                                 | Similar           |
| 27         |                                                                                                          |                                                                                                                                                                                                                   | 60.4V±20%@2kΩ                                                                                                                                                                                                     | 60.4V±10% @2kΩ                                | Note 4            |
|            |                                                                                                          |                                                                                                                                                                                                                   | 75V±20%@10kΩ                                                                                                                                                                                                      | 75V±10%@10kΩ                                  |                   |
|            | Maximum<br>Output<br>Current<br>(specify<br>units)                                                       |                                                                                                                                                                                                                   | 70mA±20%@500Ω                                                                                                                                                                                                     | 54mA±10% @500Ω                                |                   |
| 28         |                                                                                                          |                                                                                                                                                                                                                   | 30.2mA±20%@2kΩ                                                                                                                                                                                                    | 30.2mA±10% @2kΩ                               |                   |
|            |                                                                                                          |                                                                                                                                                                                                                   | 7.5mA±20%@10kΩ                                                                                                                                                                                                    | 7.5mA±10% @10kΩ                               |                   |
|            | Pulse                                                                                                    | Positive                                                                                                                                                                                                          | 175 $\mu$ s±20%                                                                                                                                                                                                   | 200 $\mu$ s±10%                               |                   |
| 29         | width<br>( $\mu$ sec)                                                                                    | Negative                                                                                                                                                                                                          | 1051 $\mu$ s (6 x (+Phase) )                                                                                                                                                                                      | 1030 $\mu$ s (5.15 x (+Phase) )               |                   |
| 30         | Pulse<br>(msec)                                                                                          | Period                                                                                                                                                                                                            | 10~1000ms                                                                                                                                                                                                         | 10~1000ms                                     | Same              |
| 31         | Max.<br>frequency                                                                                        | pulse<br>(Hz)                                                                                                                                                                                                     | 1~100Hz±20%                                                                                                                                                                                                       | 1~100Hz±10%                                   | Similar<br>Note 4 |
|            | Rate (pps)]                                                                                              |                                                                                                                                                                                                                   |                                                                                                                                                                                                                   |                                               |                   |
| 32         | Net Charge (µC per pulse)                                                                                | 0µC@500Ω, + and – pulses cancel                                                                                                                                                                                   | 0µC@500Ω, + and – pulses cancel                                                                                                                                                                                   | Same                                          |                   |
| 33         | Maximum Phase Charge, (µC)                                                                               | 8.6µC @500Ω                                                                                                                                                                                                       | 9.4µC @500Ω                                                                                                                                                                                                       | Similar Note 5                                |                   |
| 34         | Maximum Average Current, (mA)                                                                            | 1.17mA @500Ω                                                                                                                                                                                                      | 1.08mA @500Ω                                                                                                                                                                                                      |                                               |                   |
| 35         | Maximum Current Density, (mA/cm², r.m.s.)                                                                | 8.6mA/cm² @500Ω                                                                                                                                                                                                   | 9.4mA/cm² @500Ω                                                                                                                                                                                                   |                                               |                   |
| 36         | Maximum Average Power Density, (W/cm²)                                                                   | 0.135W/cm²@500Ω                                                                                                                                                                                                   | 0.141W/cm²@500Ω                                                                                                                                                                                                   |                                               |                   |
| 37         | Biocompatibility                                                                                         | ISO10993-5, ISO 10993-10                                                                                                                                                                                          | ISO10993-5, ISO 10993-10                                                                                                                                                                                          | Same                                          |                   |
| 38         | Accessories                                                                                              | Lead wires, Alligator type connectors                                                                                                                                                                             | Lead wires, Alligator type connectors                                                                                                                                                                             | Same                                          |                   |
|            | Parameters                                                                                               | Modified Device                                                                                                                                                                                                   | Predicate Device                                                                                                                                                                                                  | Remark                                        |                   |
| 1          | 510(k) Number:                                                                                           | K244030                                                                                                                                                                                                           | K202861                                                                                                                                                                                                           | --                                            |                   |
| 2          | Marketing clearance date:                                                                                | --                                                                                                                                                                                                                | 08/27/2021                                                                                                                                                                                                        | --                                            |                   |
| 3          | Device Name                                                                                              | Needle Stimulator                                                                                                                                                                                                 | Needle Stimulator                                                                                                                                                                                                 | --                                            |                   |
| 4          | Model                                                                                                    | CMNS6-3                                                                                                                                                                                                           | CMNS6-2                                                                                                                                                                                                           | --                                            |                   |
| 5          | Manufacturer                                                                                             | Wuxi Jiajian Medical<br>Instrument Co.,Ltd                                                                                                                                                                        | Wuxi Jiajian Medical<br>Instrument Co.,Ltd                                                                                                                                                                        | Same                                          |                   |
| 6          | Indications for Use                                                                                      | Needle Stimulator is an<br>electro-acupuncture stimulator<br>device, which is indicated for<br>use in the practice of<br>acupuncture by qualified<br>practitioners of acupuncture as<br>determined by the states. | Needle Stimulator is an<br>electro-acupuncture stimulator<br>device, which is indicated for<br>use in the practice of<br>acupuncture by qualified<br>practitioners of acupuncture as<br>determined by the states. | Same                                          |                   |
| 7          | Type of use                                                                                              | Prescription use                                                                                                                                                                                                  | Prescription use                                                                                                                                                                                                  | Same                                          |                   |
|            | Power Source(s)                                                                                          | DC 1.5Vx6 Type R14 or AC<br>100-240V                                                                                                                                                                              | DC 1.5Vx6 Type R14 or AC<br>100-240V                                                                                                                                                                              | Same                                          |                   |
| 8          | Method of Line<br>Current Isolation                                                                      | Type BF                                                                                                                                                                                                           | Type BF                                                                                                                                                                                                           | Same                                          |                   |
|            | Patient Leakage<br>Current                                                                               | --                                                                                                                                                                                                                | --                                                                                                                                                                                                                | Same                                          |                   |
|            | Normal<br>Condition (μΑ)                                                                                 | 2μΑ                                                                                                                                                                                                               | 2μΑ                                                                                                                                                                                                               |                                               |                   |
|            | Single Fault<br>Condition (μΑ)                                                                           | ≤50μΑ                                                                                                                                                                                                             | ≤50μΑ                                                                                                                                                                                                             |                                               |                   |
| 9          | Average DC current<br>through electrodes<br>when device is on<br>but no pulses are<br>being applied (µA) | N/A                                                                                                                                                                                                               | N/A                                                                                                                                                                                                               | Same                                          |                   |
| 10         | Number of Output<br>Modes                                                                                | 3 (continuous wave/ interrupted<br>wave/ Dense-disperse wave)                                                                                                                                                     | 3 (continuous wave/ interrupted<br>wave/ Dense-disperse wave)                                                                                                                                                     | Same                                          |                   |
|            | Number of Output<br>channels:                                                                            | 6 (3 channels at most work<br>together on single patient)                                                                                                                                                         | 6 (3 channels at most work<br>together on single patient)                                                                                                                                                         | Same                                          |                   |
| 11         | Synchronous<br>or Alternating?                                                                           | Synchronous                                                                                                                                                                                                       | Synchronous                                                                                                                                                                                                       | Same                                          |                   |
|            | Method of<br>Channel Isolation                                                                           | Transformer                                                                                                                                                                                                       | Transformer                                                                                                                                                                                                       | Same                                          |                   |
|            | Regulated Current or<br>Regulated Voltage?                                                               | Voltage Control                                                                                                                                                                                                   | Voltage Control                                                                                                                                                                                                   | Same                                          |                   |
| 13         | Software/Firmware/<br>Microprocessor<br>Control?                                                         |                                                                                                                                                                                                                   | Yes                                                                                                                                                                                                               | Yes                                           | Same              |
| 14         | Automatic Overload<br>Trip?                                                                              |                                                                                                                                                                                                                   | No                                                                                                                                                                                                                | No                                            | Same              |
| 15         | Automatic No-Load<br>Trip?                                                                               |                                                                                                                                                                                                                   | Yes                                                                                                                                                                                                               | No                                            | Similar<br>Note 1 |
| 16         | Automatic Shut Off?                                                                                      |                                                                                                                                                                                                                   | Yes                                                                                                                                                                                                               | Yes                                           | Same              |
| 17         | User<br>Override<br>Control?                                                                             |                                                                                                                                                                                                                   | Yes                                                                                                                                                                                                               | Yes                                           | Same              |
| 18         | Indicator<br>Display:                                                                                    | On/Off<br>Status?                                                                                                                                                                                                 | Yes                                                                                                                                                                                                               | Yes                                           | Same              |
|            |                                                                                                          | Low<br>Battery?                                                                                                                                                                                                   | No                                                                                                                                                                                                                | Yes                                           | Similar<br>Note 1 |
|            |                                                                                                          | Voltage/<br>Current<br>Level?                                                                                                                                                                                     | Yes                                                                                                                                                                                                               | Yes                                           | Same              |
| 19         | Timer<br>(minutes)                                                                                       | Range                                                                                                                                                                                                             | 1-100min                                                                                                                                                                                                          | 1-99min                                       | Similar<br>Note 3 |
| 20         | Compliance<br>with<br>Voluntary Standards?                                                               |                                                                                                                                                                                                                   | IEC 60601-1, IEC 60601-1-2                                                                                                                                                                                        | IEC 60601-1, IEC 60601-2-10,<br>IEC 60601-1-2 | Similar<br>Note 2 |
| 21         | Compliance with 21<br>CFR 898?                                                                           |                                                                                                                                                                                                                   | Yes                                                                                                                                                                                                               | Yes                                           | Same              |
| 22         | Weight (grams)                                                                                           |                                                                                                                                                                                                                   | 740g                                                                                                                                                                                                              | approx. 657g                                  | Similar           |
| 23         | Dimensions [W x H<br>x D]                                                                                |                                                                                                                                                                                                                   | 234*160*76mm                                                                                                                                                                                                      | 238*184*75mm                                  | Note 3            |
| 24         | Housing Materials &<br>Construction                                                                      |                                                                                                                                                                                                                   | ABS; Injection molded                                                                                                                                                                                             | ABS; Injection molded                         | Same              |
| 25         | Waveform                                                                                                 |                                                                                                                                                                                                                   | Biphasic                                                                                                                                                                                                          | Biphasic                                      | Same              |
| 26         | Shape                                                                                                    |                                                                                                                                                                                                                   | Asymmetric, square wave                                                                                                                                                                                           | Asymmetric, square wave                       | Same              |
| 27         | Maximum<br>Output<br>Voltage (volts)                                                                     |                                                                                                                                                                                                                   | 35V±20%@500Ω                                                                                                                                                                                                      | 27V±10% @500Ω                                 | Similar<br>Note 4 |
|            |                                                                                                          |                                                                                                                                                                                                                   | 60.4V±20%@2kΩ                                                                                                                                                                                                     | 60.4V±10% @2kΩ                                |                   |
|            |                                                                                                          |                                                                                                                                                                                                                   | 75V±20%@10kΩ                                                                                                                                                                                                      | 75V±10%@10kΩ                                  |                   |
|            | Maximum<br>Current                                                                                       | Output<br>(specify                                                                                                                                                                                                | 70mA±20%@500Ω                                                                                                                                                                                                     | 54mA±10% @500Ω                                |                   |
| 28         |                                                                                                          |                                                                                                                                                                                                                   | 30.2mA±20%@2kΩ                                                                                                                                                                                                    | 30.2mA±10% @2kΩ                               |                   |
|            | units)                                                                                                   |                                                                                                                                                                                                                   | 7.5mA±20%@10kΩ                                                                                                                                                                                                    | 7.5mA±10% @10kΩ                               |                   |
|            | Pulse                                                                                                    | Positive                                                                                                                                                                                                          | 175µs±20%                                                                                                                                                                                                         | 175µs±10%                                     |                   |
| 29         | width<br>(µsec)                                                                                          | Negative                                                                                                                                                                                                          | 1051µs (6 x (+Phase) )                                                                                                                                                                                            | 1051µs (6 x (+Phase) )                        |                   |
| 30         | Pulse<br>Period<br>(msec)                                                                                |                                                                                                                                                                                                                   |                                                                                                                                                                                                                   |                                               |                   |
| 30         | Pulse<br>Period<br>(msec)                                                                                | 10~1000ms                                                                                                                                                                                                         | 10~1000ms                                                                                                                                                                                                         | Same                                          |                   |
| 31         | Max.<br>pulse<br>frequency (Hz) [or<br>Rate (pps)]                                                       | 1~100Hz±20%                                                                                                                                                                                                       | 1~100Hz±10%                                                                                                                                                                                                       | Similar<br>Note 4                             |                   |
| 32         | Net Charge (µC per<br>pulse)                                                                             | 0μC@500Ω, + and – pulses<br>cancel                                                                                                                                                                                | 0μC@500Ω, + and – pulses<br>cancel                                                                                                                                                                                | Same                                          |                   |
| 33         | Maximum Phase<br>Charge, (µC)                                                                            | 8.6μC @500Ω                                                                                                                                                                                                       | 8.225μC @500Ω                                                                                                                                                                                                     | Similar<br>Note 5                             |                   |
| 34         | Maximum Average<br>Current, (mA)                                                                         | 1.17mA @500Ω                                                                                                                                                                                                      | 0.945mA @500Ω                                                                                                                                                                                                     |                                               |                   |
| 35         | Maximum Current<br>Density, (mA/cm²,<br>r.m.s.)                                                          | 8.6mA/cm² @500Ω                                                                                                                                                                                                   | 8.225mA/cm² @500Ω                                                                                                                                                                                                 |                                               |                   |
| 36         | Maximum Average<br>Power Density,<br>(W/cm²)                                                             | 0.135W/cm²@500Ω                                                                                                                                                                                                   | 0.1234W/cm²@500Ω                                                                                                                                                                                                  |                                               |                   |
| 37         | Biocompatibility…

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**Source:** [https://fda.innolitics.com/device/K244030](https://fda.innolitics.com/device/K244030)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com