← Product Code [NUH](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH) · K220150

# TENS & PMS (Model: SM9126) (K220150)

_Hong Qiangxing (Shenzhen) Electronics Limited · NUH · Feb 17, 2022 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K220150

## Device Facts

- **Applicant:** Hong Qiangxing (Shenzhen) Electronics Limited
- **Product Code:** [NUH](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH.md)
- **Decision Date:** Feb 17, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.5890
- **Device Class:** Class 2
- **Review Panel:** Neurology
- **Attributes:** Therapeutic, 3rd-Party Reviewed

## Indications for Use

TENS (3-6, 13, 14, 20, 21, 23): 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, 7-12, 15-19, 22, 24): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

## Device Story

TENS & PMS (Model: SM9126) is an over-the-counter transcutaneous electrical nerve stimulator. Device delivers electrical pulses to muscles via electrodes to provide temporary pain relief (TENS) or improve muscle performance (PMS). Operated by patient for home use. Device transforms electrical energy into therapeutic stimulation pulses. Output affects muscle activity and sensory nerve perception to manage pain or facilitate performance. No complex software or AI/ML algorithms described.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Transcutaneous electrical nerve stimulator; electrical pulse output; intended for OTC use; no specific materials, software, or connectivity details provided.

## Regulatory 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.

## Submission Summary (Full Text)

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February 17, 2022

Hong Qiangxing (Shen Zhen) Electronics Limited % Prithul Bom Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K220150

Trade/Device Name: TENS & PMS (Model: SM9126) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX Dated: January 18, 2022 Received: January 19, 2022

Dear Prithul Bom:

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.

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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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Pamela Scott, PhD Assistant Director, Neuromodulation Psychiatry Devices 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) K220150

Device Name TENS & PMS (Model: SM9126)

## Indications for Use (Describe)

TENS (3-6, 13, 14, 20, 21, 23):

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, 7-12, 15-19, 22, 24):

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) |  |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

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

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