TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator)

K143059 · Tone-A-Matic International, Inc. · NGX · Jan 26, 2015 · Physical Medicine

Device Facts

• Record ID: K143059
• Device Name: TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator)
• Applicant: Tone-A-Matic International, Inc.
• Product Code: NGX · Physical Medicine
• Decision Date: Jan 26, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

TAMTEC-HANA TENS/EMS is a powered muscle stimulator used for pain relief and muscle performance improvement. Device delivers electrical impulses via electrodes to patient's skin. TENS mode provides temporary relief of pain from sore/aching muscles in shoulder, waist, back, neck, and extremities due to exercise or household work. EMS mode stimulates healthy muscles to improve/facilitate muscle performance. Device is intended for over-the-counter use. Operation involves user-controlled settings for electrical stimulation parameters. Output affects muscle tissue via transcutaneous electrical nerve stimulation or electric muscle stimulation. Benefits include pain management and muscle conditioning.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered muscle stimulator (21 CFR 890.5850). Class II device. Product codes NGX (TENS) and NUH (EMS). Operates via electrical stimulation of nerves and muscles.

Indications for Use

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

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.

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

January 26, 2015

Tone-A-Matic International, Inc. c/o Mr. Manuel Chuck 145 Traders Boulevard East Unit 18 Mississauga, Ontario L4Z-3L3 CANADA

Re: K143059

Trade Name: TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH Dated: October 25, 2014 Received: October 28, 2014

Dear Mr. Chuck:

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. Isting 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

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device-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 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 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 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,

# Felipe Aquel -S

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

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

## 510(k) Number (if known) K143059

#### Device Name

TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator)

## Indications for Use (Describe)

TENS (Transcutaneous Electric Nerve Stimulation):

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. EMS (Electric Muscle Stimulation):

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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