OTC EMS STIMULATOR

K133965 · Shenzhen Dongdixin Technology Co., Ltd. · NGX · Jun 16, 2014 · Physical Medicine

Device Facts

• Record ID: K133965
• Device Name: OTC EMS STIMULATOR
• Applicant: Shenzhen Dongdixin Technology Co., Ltd.
• Product Code: NGX · Physical Medicine
• Decision Date: Jun 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OTC EMS stimulator MT1001 is intended to stimulate healthy muscles of the lower extremity in order to temporarily increase local blood circulation and to stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Story

OTC EMS Stimulator MT1001 is a powered muscle stimulator for over-the-counter use. Device delivers electrical impulses to healthy muscles via electrodes to induce contraction. Primary functions include temporary increase of local blood circulation and improvement of muscle performance in lower extremities. Operated by the user for home-based muscle stimulation. Output consists of controlled electrical stimulation patterns. Benefits include enhanced circulation and muscle conditioning.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and comparison to predicate devices.

Technological Characteristics

Powered muscle stimulator; electrical stimulation output; intended for lower extremity muscle application; Class II device; product code NGX.

Indications for Use

Indicated for healthy individuals to stimulate lower extremity muscles to temporarily increase local blood circulation and improve/facilitate muscle performance.

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 Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 16, 2014

Shenzhen Dongdixin Technology Co., Ltd Ms. Oilian Liu Regulatory Affairs Director No. 3 Building, Xilibaimang Xusheng Industrial Estate Nanshan District Shenzhen, CHINA 518108

Re: K133965

Trade/Device Name: OTC EMS Stimulator MT1001 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: May 21, 2014 Received: May 23, 2014

Dear Ms. Liu:

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

> .:

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Page 2 – Ms. Qilian Liu

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 Industry and Consumer Education at its toll-free 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 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,

# Felipe Aquel -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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K133965

Device Name

OTC EMS Stimulator MT1001

#### Indications for Use (Describe)

The OTC EMS stimulator MT1001 is intended to stimulate healthy muscles of the lower extremity in order to temporarily increase local blood circulation and 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)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

# FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Date: 2014.06.16 17:22:12 -04'00'

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

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