TENS & PMS

K201354 · Hong Qiangxing (Shenzhen) Electronics Limited · NGX · Dec 11, 2020 · Physical Medicine

Device Facts

• Record ID: K201354
• Device Name: TENS & PMS
• Applicant: Hong Qiangxing (Shenzhen) Electronics Limited
• Product Code: NGX · Physical Medicine
• Decision Date: Dec 11, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TENS (1,3,4,5,6,21): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS (2,7,8,9,10,11,12,13,14,15,16,17,18,19,20,22,23,24): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Story

TENS & PMS is a portable, DC 3.7V battery-powered device offering Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) in one unit. It uses electrodes to deliver specific electric currents to the skin. The device features multiple models (SM9079, SM9126, SM9186, SM9196) with varying treatment programs. It is intended for OTC use by patients for pain relief and muscle performance improvement. The device includes electrode pads, cables, and a USB charger. Healthcare providers or patients use the device to apply electrical stimulation; the output affects muscle performance or provides pain relief. Benefits include temporary pain relief and facilitated muscle performance.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with AAMI/ANSI ES60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 62133, and IEC 60601-1-11 confirmed.

Technological Characteristics

Portable, battery-powered (DC 3.7V) stimulator. Materials: ABS housing. Sensing/Actuation: Voltage-controlled electrical stimulation via electrodes. Waveform: Pulsed, symmetric, biphasic. Connectivity: USB for charging. Sterilization: N/A. Standards: AAMI/ANSI ES60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 62133, IEC 60601-1-11. Biocompatibility: ISO 10993-5 and ISO 10993-10.

Indications for Use

Indicated for temporary relief of pain in sore/aching muscles (shoulder, waist, back, neck, arms, legs) due to exercise or household strain, and for stimulation of healthy muscles to improve/facilitate muscle performance. Intended for OTC use.

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Predicate Devices

• SM TENS & PMS (K121719)

Submission Summary (Full Text)

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December 11, 2020

Hong Qiangxing (Shen Zhen) Electronics Limited % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No. 19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China

Re: K201354

Trade/Device Name: TENS & PMS Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX. NUH Dated: September 3, 2020 Received: September 14, 2020

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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,

For 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) K201354

Indications for Use (Describe)

Device Name TENS & PMS

| Model: | SM9079 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| TENS | (1,3,4,5,6,21): |
| To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. | |
| PMS | (2,7,8,9,10,11,12,13,14,15,16,17,18,19,20,22,23,24): |
| It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. | |
| Model: | SM9126 |
| TENS | (3,4,5,6,11,12,16): |
| To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. | |
| PMS | (1,2,7,8,9,10,13,14,15): |
| It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. | |
| Model: | SM9186 |
| TENS | (3,4,7,8,11): |
| To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. | |
| PMS | (1,2,5,6,9,10,12): |
| It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. | |
| Model: | SM9196 |
| TENS | (10~15): |
| To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. | |
| PMS | (1~9): |
| It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. | |

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

| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
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4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126

# 510(k) Summary

[As required by 21 CFR 807.92]

#### 1. Submission Information:

| 510(k) Number: | K201354 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | December 11, 2020 |
| Type of 510(k) Submission: | Traditional |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | Hong Qiangxing(Shen Zhen) Electronics Limited<br>4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an<br>District, Shenzhen City, Guangdong, China 518126 |
| Contact: | Doris Dong<br>[Consultant, from Shanghai CV Technology Co., Ltd.]<br>Add: Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China<br>E-mail: [e-mail]<br>Tel: [phone] / Fax: [phone] |
| 2. Device Description: | |
| Proprietary Name: | TENS & PMS |
| Common Name: | TENS & PMS |
| Classification Name: | Powered muscle stimulator<br>Transcutaneous electrical nerve stimulator for pain relief |
| Regulation Number: | 21 CFR 890.5850, 21 CFR 882.5890 |
| Product Code: | NGX, NUH |
| Device Class: | II |
| Review Panel: | Neurology & Physical Medicine |
| Device Description: | TENS & PMS is a portable and DC 3.7V battery powered multifunction<br>device with multiple models, offering both Transcutaneous Electrical Nerve<br>Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in<br>one device.<br>The device is equipped with accessories of electrode pads, electrode cables,<br>a battery charger, and one USB cable. The electrode cables are used to<br>connect the pads to the device; the USB cable is used to connect the charger<br>and the built-in lithium battery. All accessories, including USB cables,<br>electrode pads, electrode cables, chargers can only be changed or replaced<br>by a qualified person. |
| Indications for use: | Model: SM9079<br>TENS(1,3,4,5,6,21):<br>To be used for temporary relief of pain associated with sore and aching<br>muscles in the shoulder, waist, back, neck, upper extremities (arm), and<br>lower extremities (leg) due to strain from exercise or normal household<br>work activities.<br>PMS(2,7,8,9,10,11,12,13,14,15,16,17,18,19,20,22,23,24):<br>It is intended to be used to stimulate healthy muscles in order to improve<br>and facilitate muscle performance. |

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4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126

#### Model: SM9126

TENS(3.4.5.6.11.12.16):

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

PMS(1,2,7,8,9,10,13,14,15):

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

#### Model: SM9186

#### TENS(3,4,7,8,11):

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

PMS(1,2,5,6,9,10,12):

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

#### Model: SM9196

TENS(10~15):

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

PMS(1~9):

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

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4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126 3. Working principle

The device uses electrodes to send a specific electric current to the skin. TENS(Transcutaneous electrical nerve stimulation) mode is to relieve pain using electrical stimulation. PMS(Powered Muscle Stimulation) mode is to stimulate healthy muscles in order to improve performance by electrical stimulation.

## 4. Substantial Equivalence to Predicate device: Basic Unit Characteristics

Table 1-

| Parameters | New Device | Predicate Device | Remark | |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|----------------|
| 510(k) Number | K201354 | K121719 | -- | |
| Device Name | TENS & PMS | SM TENS & PMS | -- | |
| Model | SM9079 | No | -- | |
| Manufacturer | Hong Qiangxing (Shenzhen)<br>Electronics Limited | Hong Qiangxing (Shenzhen)<br>Electronics Limited | Same | |
| Intended use | TENS(1,3~6,21):<br>To be used for temporary relief<br>of pain associated with sore and<br>aching muscles in the shoulder,<br>waist, back, neck, upper<br>extremities (arm), and lower<br>extremities (leg) due to strain<br>from exercise or normal<br>household work activities.<br>PMS(2,7~20,22~24):<br>It is intended to be used to<br>stimulate healthy muscles in<br>order to improve and facilitate<br>muscle performance. | TENS(1,3,4,5,6):<br>To be used for temporary relief<br>of pain associated with sore and<br>aching muscles in the shoulder,<br>waist, back, neck, upper<br>extremities (arm), and lower<br>extremities (leg) due to strain<br>from exercise or normal<br>household work activities.<br>PMS(1,2,3,6):<br>It is intended to be used to<br>stimulate healthy muscles<br>in<br>order to improve and facilitate<br>muscle performance. | Same | |
| Type of use | OTC | OTC | Same | |
| Power Source(s) | DC 3.7V lithium battery | DC<br>3.7V<br>lithium battery | Same | |
| - Method of Line<br>Current Isolation | Type BF | Type BF | Same | |
| Patient Leakage | | -- | Same | |
| Current | | | | |
| | Normal | < 10μΑ | < 10μΑ | |
| Condition (μΑ) | | | | |
| | - Single Fault | < 50μA | < 50μA | |
| Condition (μΑ) | | | | |
| Average | DC | < 0.01μA | < 0.01μA | Same |
| current | through | | | |
| electrodes | when | | | |
| device is on but no | | | | |
| pulses are being | | | | |
| applied (µA) | | | | |
| Number of Output | | 24 | 6 | Similar |
| Modes | | | | Note 1 |
| Number of Output | | 2 | 2 | Same |
| channels: | | | | |
| | | Alternating | Synchronous | Similar Note 2 |
| Synchronous | Or | | | |
| Alternating? | | | | |
| | - Method of | Voltage transformer | Voltage transformer | Same |
| Channel Isolation | | Isolation | Isolation | |
| Regulated Current | | Voltage control | Voltage control | Same |
| or | Regulated | | | |
| Voltage? | | | | |
| Software/Firmwar | | | | |
| | | Software | Software | Same |
| e/Microprocessor<br>Control? | | | | |
| | | | | |
| Automatic | | No | No | Same |
| Overload Trip? | | | | |
| Automatic | | No | No | Same |
| No-Load Trip? | | | | |
| Automatic | Shut | Yes | Yes | Same |
| Off? | | | | |
| User | Override | Yes | Yes | Same |
| Control? | | | | |
| Indicato | On/Off | Yes | Yes | Same |
| r | Status | | | |
| Display | Low | Yes | Yes | Same |
| | Battery | | | |
| | Voltage | Yes | Yes | Same |
| | /Curren | | | |
| | t Level | | | |
| Timer | Range | 10 ~ 60 minutes, 10 | 10 ~ 60 minutes, 10 | Same |
| (minutes) | | min/step | min./step | |
| Compliance | with | Yes. | Yes. | Same |
| Voluntary | | AAMI/ANSI ES 60601-1 | AAMI/ANSI | |
| | Hong Qiangxing(Shen Zhen) Electronics Limited<br>4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen City, Guangdong, China 518126…