Everyway Wireless TENS & EMS Unit

K181707 · Everyway Medical Instruments Co.,Ltd · NUH · Sep 26, 2018 · Neurology

Device Facts

• Record ID: K181707
• Device Name: Everyway Wireless TENS & EMS Unit
• Applicant: Everyway Medical Instruments Co.,Ltd
• Product Code: NUH · Neurology
• Decision Date: Sep 26, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

TENS: 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. EMS: intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The various types of muscle work that the EMS can impose on the stimulated muscles are able to improve or facilitate muscle performance. The EMS may therefore be considered a technique of muscle training.

Device Story

Everyway Wireless TENS & EMS Unit (Model EM-5200) is a transcutaneous electrical nerve stimulator and electrical muscle stimulator. Device delivers electrical pulses via electrodes to skin surface. TENS mode provides temporary pain relief for sore/aching muscles; EMS mode stimulates healthy muscles to improve performance. Device is intended for over-the-counter use. User operates device to select stimulation parameters; output affects muscle/nerve activity to manage pain or facilitate training. Wireless design allows portability.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

Transcutaneous electrical nerve and muscle stimulator. Battery-powered, wireless form factor. Delivers biphasic electrical pulses. Controls include intensity, frequency, and pulse width settings. Class II device under 21 CFR 882.5890. Product codes NUH and NGX.

Indications for Use

Indicated for adults experiencing temporary pain in low back or extremities due to strain from exercise or daily activities (TENS) and for stimulation of healthy muscles to improve or facilitate muscle performance (EMS).

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.

Predicate Devices

• Everyway Medical Instruments Co., Ltd. TENS/EMS Unit (K162635)

Submission Summary (Full Text)

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September 26, 2018

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

Re: K181707

Trade/Device Name: Everyway Wireless TENS & EMS Unit, Model EM-5200 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: June 26, 2018 Received: June 28, 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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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.

## Pamela D. Scott -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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## Indications for Use

510(k) Number (if known) K181707

Device Name

EM-5200 Wireless TENS & EMS Unit.

Indications for Use (Describe)

TENS: 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.

EMS: intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The various types of muscle work that the EMS can impose on the stimulated muscles are able to improve or facilitate muscle performance. The EMS may therefore be considered a technique of muscle training.

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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