OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)

K130802 · Shenzhen Dongdixin Technology Co., Ltd. · NUH · Sep 16, 2013 · Neurology

Device Facts

• Record ID: K130802
• Device Name: OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
• Applicant: Shenzhen Dongdixin Technology Co., Ltd.
• Product Code: NUH · Neurology
• Decision Date: Sep 16, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MT9001 OTC TENS/EMS stimulator TENS: The device is designed 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: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. LT3060 OTC TENS stimulator TENS: The device is designed 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.

Device Story

OTC Electrical stimulator models MT9001 and LT3060 are transcutaneous electrical nerve stimulators (TENS) and electrical muscle stimulators (EMS). Devices deliver electrical pulses to muscles/nerves via skin electrodes. MT9001 provides both TENS and EMS functions; LT3060 provides TENS only. Intended for home use by patients for pain relief from muscle strain or muscle performance improvement. Operation involves user-controlled settings for stimulation intensity and parameters. Output affects muscle/nerve activity to provide therapeutic benefit. No complex software or AI algorithms described.

Clinical Evidence

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

Technological Characteristics

Transcutaneous electrical nerve stimulator (TENS) and electrical muscle stimulator (EMS). Class II device. Operates via electrical pulse generation delivered through surface electrodes. Standalone device for OTC use.

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 work strain; also indicated for stimulation of healthy muscles to improve/facilitate muscle performance (MT9001 only). Intended for over-the-counter 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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Public Health Service

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

September 16, 2013

Shenzhen Dongdixin Technology Co., Ltd % Mr. Jianping Kang, R.A. Director No. 3 Bldg. Xiliyangguang Industrial Estate Xilixiaobaimang Shenzhen, Guangdong Province China 518108

Re: K130802

Trade Name: OTC Electrical stimulator Models MT9001, LT3060 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: August 16, 2013 Received: August 26, 2013

#### Dear Mr. Kang:

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

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### Page 2 - Mr. Jianping Kang

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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHO/fices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Reportal/roblem/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 hup://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): K130802

Device Name: OTC Electrical stimulator Models MT9001, LT3060

Indications For Use:

### MT9001 OTC TENS/EMS stimulator

TENS: The device is designed 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: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

### LT3060 OTC TENS stimulator

TENS: The device is designed 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.

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

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

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Concurrence of Center for Devices and Radiological Health (CDRH)

## Joyce M. Whang -S

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