Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)

K231425 · Wuxi Jiajian Medical Instrument Co., Ltd. · NUH · Mar 27, 2024 · Neurology

Device Facts

• Record ID: K231425
• Device Name: Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)
• Applicant: Wuxi Jiajian Medical Instrument Co., Ltd.
• Product Code: NUH · Neurology
• Decision Date: Mar 27, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Transcutaneous Electrical Nerve Stimulator (Model:TENS WMPS2-1) can be used for the symptomatic relief of chronic intractable pain, post traumatic pain adjunctive treatment, and post-surgical pain adjunctive treatment.

Device Story

TENS WMPS2-1 is a lithium battery-powered transcutaneous electrical nerve stimulator; delivers gentle electrical current to nerves/muscles via skin-applied electrodes to relieve pain. Device features 16 programs (12 standard, 4 editable); includes electronic stimulatory module, lead wires, electrodes, and adapter. Operated by patient (OTC use) in home or clinical settings. User applies electrodes to skin; selects program via device interface. Output parameters (voltage, current, pulse width/frequency) are controlled by internal microprocessor. Healthcare providers use device to provide adjunctive pain management; patient benefits from non-pharmacological pain relief. Device includes two output channels for electrode connection.

Clinical Evidence

No clinical data included. Substantial equivalence established via bench testing only.

Technological Characteristics

ABS plastic housing; lithium battery-powered (DC 3.7V). Biphasic waveform; 2 output channels. Microprocessor-controlled stimulation. Connectivity: wired electrodes. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11. Dimensions: 140x60x20mm. Weight: ~106g.

Indications for Use

Indicated for symptomatic relief of chronic intractable pain, post-traumatic pain, and post-surgical pain in patients requiring adjunctive treatment.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• Transcutaneous Electrical Nerve Stimulator (K210223)

Reference Devices

• Jiajian® Pointoselect Digital (K123958)

Submission Summary (Full Text)

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March 27, 2024

Wuxi Jiajian Medical Instrument Co., Ltd % Doris Dong General manager Shanghai CV Technology Co., Ltd. Room 602, No.19 Dongbao Road, Songjiang Area, Shanghai. Shanghai 201613 China

### Re: K231425

Trade/Device Name: Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: December 28, 2023 Received: December 28, 2023

### 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.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Pamela D. Scott -S

Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known) K231425

#### Device Name

Transcutaneous Electrical Nerve Stimulator(TENS WMPS2-1)

Indications for Use (Describe)

Transcutaneous Electrical Nerve Stimulator (Model:TENS WMPS2-1) can be used for the symptomatic relief of chronic intractable pain, post traumatic pain adjunctive treatment, and post-surgical pain adjunctive treatment.

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

Prescription Use (Part 21 CFR 801 Subpart D)

|X | 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: | K231425 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | May 10, 2023 |
| Type of 510(k) Submission: | Traditional 510(k) |
| Submitter/Manufacturer: | Wuxi Jiajian Medical Instrument Co., Ltd.<br>No. 35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi, Jiangsu, China<br>214116<br>E-mail: [e-mail]<br>Tel: [phone] |
| Contactor: | Doris Dong<br>[Consultant, from Shanghai CV Technology Co., Ltd.]<br>Add: Room 602, No. 19 Dongbao Road, Songjiang Area, Shanghai,<br>201613 China<br>E-mail: [e-mail]<br>Tel: [phone] / Fax: [phone] |

### 2. Device Description

| Proprietary Name: | Transcutaneous Electrical Nerve Stimulator |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model: | TENS WMPS2-1 |
| Common Name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Classification Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | NUH |
| Device Class: | 2 |
| Regulation Number: | 21 CFR 882.5890 |
| Review Panel: | Neurology |
| Indications for use: | Transcutaneous Electrical Nerve Stimulator (Model:TENS WMPS2-1) can<br>be used for the symptomatic relief of chronic intractable pain, post<br>traumatic pain adjunctive treatment, and post-surgical pain adjunctive<br>treatment. |
| Device Description: | Transcutaneous Electrical Nerve Stimulator sends gentle electrical current<br>to underlying nerves and muscle groups via electrodes applied onto the skin<br>to relieve pain.<br>The device has 16 programs (12 standard programs and 4 editable<br>programs). It is a lithium battery-powered device comprising the electronic<br>stimulatory module, the accessories of lead wires, the electrodes and the<br>adapter.<br>Two outlet sockets are used to connect skin electrodes by lead wires. The<br>accessories of electrodes are 510(k) cleared devices (K192568). Size<br>50*50mm. |

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### 3. Predicate Device Identification

| Predicate 510(k) Number: | K210223 |
|------------------------------------|--------------------------------------------|
| Marketing Clearance Date: | December 15,2021 |
| Product Name: | Transcutaneous Electrical Nerve Stimulator |
| Manufacturer: | Top-Rank Health Care Co.,Ltd. |
| Reference Predicate 510(k) Number: | K123958 |
| Marketing clearance date: | October 28,2013 |
| Product name: | Jiajian® Pointoselect Digital |
| Manufacturer: | Wuxi Jiajian Medical Instrument Co., Ltd |

| Parameters | New Device | Predicate Device | Reference<br>Predicate Device | Comparison | |
|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-------------------|
| 510(k) Number | K231425 | K210223 | K123958 | -- | |
| Device Name | Transcutaneous<br>Electrical Nerve<br>Stimulator | Transcutaneous<br>Electrical Nerve<br>Stimulator | Jiajian® Pointoselect<br>Digital | -- | |
| Model | TENS WMPS2-1 | TOPTENS-01 | | -- | |
| Manufacturer | Wuxi Jiajian<br>Medical Instrument<br>Co., Ltd | Top-Rank Health<br>Care Co.,Ltd. | Wuxi Jiajian<br>Medical Instrument<br>Co., Ltd | -- | |
| Indications for use | Transcutaneous<br>Electrical<br>Nerve<br>Stimulator<br>(Model:TENS<br>WMPS2-1) can be<br>used<br>for<br>the<br>symptomatic relief<br>of chronic<br>intractable pain,<br>post traumatic pain<br>adjunctive<br>treatment,<br>and<br>post-surgical pain<br>adjunctive<br>treatment. | The TOPTENS-01<br>can be used for the<br>symptomatic relief<br>of chronic<br>intractable pain,<br>post traumatic pain<br>adjunctive<br>treatment, and<br>post-surgical pain<br>adjunctive<br>treatment. | Jiajian® Pointoselect<br>Digital is intended<br>for use in the<br>symptomatic relief<br>of chronic<br>intractable pain,<br>postoperative pain,<br>and acute pain. | Same | |
| Type of use | OTC | OTC | Prescription use | Same | |
| Power Source(s) | DC3.7 V Li-battery<br>powered | DC 4.5V, 3 AAA<br>batteries | DC 9V battery,<br>Type 6F22 | Similar<br>Note 1 | |
| - Method of Line<br>Current Isolation | N/A | N/A | N/A | Same | |
| - Patient Leakage<br>Current | -- | -- | -- | Same | |
| - Normal Condition | 2μA | 2μA | 20μA | | |
| (μΑ) | | | | | |
| - Single Fault<br>Condition (μΑ) | | N/A | N/A | N/A | |
| Average DC current<br>through electrodes<br>when device is on<br>but no pulses are<br>being applied (µA) | | <0.01μΑ | Not Published | Not Published | Similar<br>Note 2 |
| Number of program | | 16 | 9 | 1 | Similar<br>Note 2 |
| Number of Output<br>channels: | | 2 | 2 | 1 | Same |
| - Synchronous or<br>Alternating? | | Alternating | Synchronous | N/A | Similar<br>Note 2 |
| - Method of<br>Channel Isolation | | By Transformer | By enclosure | N/A | Similar<br>Note 2 |
| Regulated Current<br>or Regulated<br>Voltage? | | Current control | Voltage control | Current control | Similar<br>Note 1 |
| Software/Firmware/<br>Microprocessor<br>Control? | | Yes | Yes | Yes | Same |
| Automatic Overload<br>Trip? | | No | No | No | Same |
| Automatic No-Load<br>Trip? | | No | Yes | No | Similar<br>Note 2 |
| Automatic Shut<br>Off? | | Yes | Yes | Yes | Same |
| User Override<br>Control? | | Yes | No | No | Similar<br>Note 2 |
| | On/Off<br>Status? | Yes | Yes | Yes | Same |
| Indicator<br>Display | Low<br>Battery? | Yes | Yes | Yes | Same |
| | Voltage/<br>Current<br>Level? | Yes | Yes | Yes | Same |
| Timer Range<br>(minutes) | | 10~99 min | 50~60 min<br>(5,10,15,20,25,30,35<br>,40, 45,50,55and 60<br>min selectable) | Manually controlled | Similar<br>Note 3 |
| Compliance with<br>Voluntary<br>Standards? | | AAMI/ANSI ES<br>60601-1, IEC<br>60601-1-2, IEC<br>60601-2-10, IEC<br>60601-1-11 | AAMI/ANSI ES<br>60601-1, IEC<br>60601-1-2, IEC<br>60601-2-10, IEC<br>60601-1-11 | AAMI/ANSI ES<br>60601-1, IEC<br>60601-1-2, IEC<br>60601-2-10 | Same |

### 4. Substantially Equivalent Comparison Conclusion

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| Compliance with 21<br>CFR 898? | Yes | Yes | Yes | Same |
|-------------------------------------------------|-----------------------------------------------|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------|
| Weight (grams) | Approx.106g | 0.18 (Battery<br>Excluded).lbs | 123g | Similar<br>Note 3 |
| Dimensions (mm)<br>[W x H x D] | 140*60*20mm | 2.32*4.96*1.18 mm | 115*60*30mm | Similar<br>Note 3 |
| Housing Materials<br>& Construction | ABS | Plastic (ABS)<br>enclosure | ABS; Injection<br>molded | Same |
| Waveform | Biphasic | Biphasic | Biphasic | Same |
| Shape | Square | Square | Asymmetric<br>biphasic square<br>wave | Same |
| Maximum Output<br>Voltage (volts) | Program 1 | Mode 4 | -- | Similar<br>Note 4 |
| | 15V±20% @500Ω | 23V @500Ω | 6.6V±15%@500Ω | |
| | 60V±20% @2kΩ | 60V@2kΩ | 26.0 ±15%@2kΩ | |
| | 85V±20% @10kΩ | 100V @10kΩ | 125V ±15% @10kΩ | |
| Maximum Output<br>Current (specify<br>units) | Program 1 | Mode 4 | -- | |
| | 30mA±20% @500Ω | 46mA @500Ω | 13.2mA±15%<br>@500Ω | |
| | 30mA±20% @2kΩ | 30mA @2kΩ | 13.0mA±15%<br>@2kΩ | |
| | 8.5mA±20% @10kΩ | 10mA @10kΩ | 12.5mA±15%<br>@10kΩ | |
| Pulse width (μsec) | 75-300μs±20% | 100-260μs | 60-120μs | |
| Pulse Period (msec) | 8.33-1000ms | 6.67-16.67ms | 55.6-500ms | |
| Max. pulse<br>frequency (Hz) [or<br>Rate (pps)] | 1-120Hz±20% | 60-150Hz | 2-18Hz | |
| Net Charge (μC per<br>pulse) | 0μC<br>@500Ω(Method:<br>Balanced<br>waveform) | 0μC<br>@500Ω(Method:<br>Balanced<br>waveform) | 0μC @500Ω, + and<br>– pulses cancel | Same |
| Maximum Phase<br>Charge, (μC) | 9μC @500Ω | 17.16μC @500Ω | 2.4μ C@500Ω | |
| Maximum Average<br>Current, (mA) | 2.16mA @500Ω | 2.22mA @500Ω | Not Published | |
| Maximum Current<br>Density, (mA/cm², r.m.s.) | 0.043mA/cm²<br>@500Ω | 0.14mA/cm²<br>@500Ω | 12.08mA/cm²@500Ω | Similar<br>Note 5 |
| Maximum Average<br>Power Density,<br>(mW/cm²) | 1.30mW/cm²<br>@500Ω | 1.50mW/cm²<br>@500Ω | 0.0036W/cm²@500Ω | |
| Accessories | Electrodes, cables,<br>adapter | Electrodes, cables | 1 pcs. of hand probe<br>for stimulation with<br>lead wire;<br>1 pcs. of hand<br>electrode with lead<br>wire | Similar<br>Note 3 |
| Comparison in details: | | | | |

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### Note 1:

Although the proposed device's power source(s) and output intensity control are a little different from those of the predicate device, they all comply with IEC 60601-1 requirements. So the differences will not raise any safety or effectiveness issues.

#### Note 2:

The proposed device's average DC current at no load, number of output modes, channel output design and isolation methods,automatic no trip and user override control are different from those of the primary predicate device. As the proposed device and predicate device adopt the same fundamental output technology and have similar treatment effect, therefore, the proposed device is considered to be substantially equivalent. Also, the proposed device had passed AAMI / ANSI ES60601-1 and IEC 60601-2-10 tests, so these differences will not raise any new safety and effectiveness issues.

#### Note 3:

The time range, weight, dimensions and accessories of the proposed device are a little different from those of the predicate device, depending on the design and sales requirements of the product. But these differences are insignificant in terms of safety or effectiveness.

#### Note 4:

There are some differences in the maximum output voltage and maximum output current between the proposed device and the predicate device. Based on the calculation of maximum current density, maximum average power density, these parameters don't exceed the safety limit. Also, these parameters have passed IEC 60601-2-10 test codes and all deviation and the worst cases have been considered in risk analysis report..So these differences will not raise any new safety and effectiveness issues. Although the pulse width, pulse period and frequency of the proposed device are a little different from those of the predicate device, but they are all in compliance with IEC 60601-2-10 requirements. The minor differences of function specification will not raise any safety or effectiveness issue, either.

#### Note 5:

The net charge and maximum phase charge of the proposed device are different from those of the predicate device, but both of them comply with IEC 60601-1 and IEC 60601-2-10 requirements, so the differences will not raise any safety or effectiveness issues. The maximum average current, maximum current density, maximum average power density have some differences between the proposed device and the predicate device. But both of them meet the maximum average current of <10mA, the maximum current density of <2mA/cm² and the maximum average power density of <0.25W/cm². Also, all programs have passed AAMI/ANSI ES 60601-1 and IEC 60601-2-10 tests. Therefore, these differences will not raise any new safety and effectiveness issues.

#### 5. Non-Clinical Test Conclusion

Bench tests were conducted on Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate devices. The following tests were performed on the proposed device:

• ANSI AAMI ES60601-1: 2005/(R) 2012 And A1: 2012, C1: 2009/(R) 2012 And A2: 2010/(R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1: 2005, MOD);

• IEC 60601-2-10 Edition 2.1 2016-04, Medical Electrical Equipment - Part 2-10: Particular Requirements for the Basic Safety and Essential Performance Of Nerve and Muscle Stimulators;

· IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests;

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• IEC 60601-1-11 Edition 2.0 2015-01 Medical Electrical Equipment -- Part 1-11: General Requirements For Basic Safety and Essential Performance -- Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Equipment and Medical Electrical Systems Used in Home Healthcare Environment

### 6. Clinical Test

Clinical data were not included in this submission.

### 7. Conclusion

The conclusion drawn from the non-clinical tests demonstrates that the device performs well and is as safe, and effective as the legally marketed device identified in the submission. Thus, the subject device is substantially equivalent to the predicate device.