EV-804 OTC Pain Relief TENS

K172919 · Everyway Medical Instruments Co.,Ltd · NUH · Apr 19, 2018 · Neurology

Device Facts

• Record ID: K172919
• Device Name: EV-804 OTC Pain Relief TENS
• Applicant: Everyway Medical Instruments Co.,Ltd
• Product Code: NUH · Neurology
• Decision Date: Apr 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OTC Pain Relief TENS, model EV-804, is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities

Device Story

EV-804 is a transcutaneous electrical nerve stimulator (TENS) for OTC pain relief. Device delivers electrical pulses via skin electrodes to stimulate nerves for symptomatic pain relief. Operated by patient for home use. Provides temporary relief of muscle soreness/aches in low back and extremities caused by exercise or daily activities. Output parameters (pulse width, frequency, intensity) are user-adjustable to manage comfort and therapeutic effect. Benefits include non-pharmacological pain management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison to predicate devices.

Technological Characteristics

TENS device; electrical stimulation via skin electrodes; battery-powered; portable form factor; user-adjustable pulse frequency, width, and intensity; standard TENS output circuitry.

Indications for Use

Indicated for temporary relief of pain associated with sore and aching muscles in the low back, arms, and legs due to strain from exercise or normal household and work activities. 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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April 19, 2018

Everyway Medical Instruments Co., Ltd. Paul Hung Official Correspondent 3F1., No. 5, Lane 155, Sec. 3, Beishen Rd. Shenkeng Dist New Taipei City, 22203 Tw

Re: K172919

Trade/Device Name: EV-804 OTC Pain Relief TENS Regulation Number: 21 CFR 8825890 Regulation Name: transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: March 20, 2018 Received: March 22, 2018

Dear Paul Hung:

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# William J. Heetderks -S 2018.04.19 13:04:34 -04'00'

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: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K172919

Device Name

Everyway OTC Pain Relief TENS/Model EV-804

#### Indications for Use (Describe)

The OTC Pain Relief TENS, model EV-804, is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities

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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