TENS AND POWERED MUSCLE STIMULATOR

K143268 · Shenzhen As-Tec Technology Co., Ltd. · NUH · Jul 21, 2015 · Neurology

Device Facts

• Record ID: K143268
• Device Name: TENS AND POWERED MUSCLE STIMULATOR
• Applicant: Shenzhen As-Tec Technology Co., Ltd.
• Product Code: NUH · Neurology
• Decision Date: Jul 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Transcutaneous Electrical Nerve Stimulation (TENS): 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. Powered Muscle Stimulation (PMS): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Story

Device provides Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief and Powered Muscle Stimulation (PMS) for muscle performance. Operates by delivering electrical impulses to muscles/nerves via electrodes. Intended for over-the-counter (OTC) use by patients for temporary relief of sore/aching muscles or to stimulate healthy muscles. Device is a portable stimulator; user applies electrodes to target areas; selects stimulation parameters to manage pain or facilitate muscle activity. Benefits include non-pharmacological pain management and muscle conditioning.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Powered muscle stimulator and TENS unit. Electrical stimulation via surface electrodes. Device operates as a portable stimulator. Technical specifications and materials are consistent with standard Class II electrical muscle stimulators under 21 CFR 890.5850.

Indications for Use

Indicated for individuals experiencing muscle pain in the shoulder, waist, back, neck, arms, or legs due to exercise or household strain (TENS) and for individuals seeking to improve or facilitate performance in healthy muscles (PMS).

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 21, 2015

Shenzhen As-tec Technology Co., Ltd % Doris Dong Manager Shanghai Cv Technology Co., Ltd Room 1706 Yuesha Building, No.128 Songle Rd., Songjiang Area Shanghai. 201600 CN

Re: K143268

> Trade/Device Name: TENS and Powered Muscle Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH Dated: September 26, 2014 Received: November 13, 2014

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. 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 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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Michael J.Hoffmann -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K143268

Device Name TENS and Powered Muscle Stimulator

Indications for Use (Describe)

Transcutaneous Electrical Nerve Stimulation (TENS):

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.

Powered Muscle Stimulation (PMS):

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)

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

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