TCM MASSAGER

K130150 · Anhui Jinjianqiao Med-Tech Co,. , Ltd. · NUH · Sep 26, 2013 · Neurology

Device Facts

• Record ID: K130150
• Device Name: TCM MASSAGER
• Applicant: Anhui Jinjianqiao Med-Tech Co,. , Ltd.
• Product Code: NUH · Neurology
• Decision Date: Sep 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

Dohenes Electrical Stimulators are transcutaneous electrical nerve stimulators (TENS) used for pain relief and muscle stimulation. The device delivers electrical impulses to the body via electrodes to stimulate muscles and nerves. It is intended for over-the-counter (OTC) use by patients for temporary relief of muscle pain from exercise or household activities and to facilitate muscle performance. The device operates by applying electrical stimulation to healthy muscles; the user controls the intensity and application. It provides non-invasive, localized stimulation to the specified body areas to alleviate discomfort and improve muscle function.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Transcutaneous electrical nerve stimulator (TENS). Class II device (21 CFR 882.5890). Product codes: NUH, NGX. Electrical stimulation output for nerve/muscle activation.

Indications for Use

Indicated for temporary relief of pain in shoulder, waist, back, neck, arms, and legs caused by exercise or household strain; also indicated for stimulation of healthy muscles to improve/facilitate muscle performance. For OTC use.

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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

#### September 26, 2013

Anhui Jinjianqiao Med-Tech Co., LTD. c/o Field Fu Shenzhen Zytc Consulting Co.. LTD. 05c.Fuhai Kangle Building. Nashan District Shenhen Shenzhen, Guangdong China

Re: K130150

Trade/Device Name: Dohenes Electrical Stimulators Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH. NGX Dated: July 24, 2013 Received: August 14, 2013

Dear Field Fu:

We have reviewed your Section 510(k) premarket notilication 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 10 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 vour 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

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

hup://www.fda.gov/MedicalDevices/Safets/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours.

# Joyce M. Whang -S

for Victor Krauthamer. Ph.D. Acting 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):__ K130150

Device Name: Dohenes Electrical Stimulators

Indications For Use:

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.

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

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use × (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

# Joyce M. Whang -S

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