Electronic Pulse Stimulator

K153520 · Jkh Health Co., Ltd. · NUH · May 5, 2016 · Neurology

Device Facts

• Record ID: K153520
• Device Name: Electronic Pulse Stimulator
• Applicant: Jkh Health Co., Ltd.
• Product Code: NUH · Neurology
• Decision Date: May 5, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TENS (Modes 1, 2, 4, 5, 6) To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, arm, and leg, due to strain from exercise or normal household and work activities. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. PMS (Modes 1 and 3) To stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

Device Story

Electronic Pulse Stimulator delivers electrical pulses via electrodes to skin. Operates in TENS mode for pain relief or PMS mode for muscle stimulation. User-controlled intensity and mode settings. Used OTC by patients for muscle strain, chronic pain, or muscle conditioning. Output affects nerve/muscle tissue to provide symptomatic relief or facilitate muscle performance. Benefits include non-pharmacological pain management and muscle toning.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Transcutaneous electrical nerve stimulator; electrical pulse output; multi-mode operation (TENS/PMS); OTC form factor; battery-powered; non-invasive electrode interface.

Indications for Use

Indicated for adults seeking temporary relief of pain from sore/aching muscles (shoulder, waist, arm, leg) due to strain, chronic intractable pain, or arthritis. Also indicated for healthy individuals to improve muscle tone, firmness, and strength (arms, abdomen, legs, buttocks) and to temporarily increase local blood circulation in lower extremity muscles. Not for medical treatment of diseases.

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

May 5, 2016

JKH Health Co., Ltd. % Bill Quanqin Dai, Ph.D. Application Correspondent 1142 S. Diamond Bar Blvd. #861 Diamond Bar, CA 91765

Re: K153520

Trade/Device Name: Electronic Pulse Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX, NYN Dated: March 30, 2016 Received: April 5, 2016

Dear Dr. Dai:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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.

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,

# Michael J.Hoffmann -A

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) K153520

Device Name Electronic Pulse Stimulator

### Indications for Use (Describe)

TENS (Modes 1, 2, 4, 5, 6)

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, arm, and leg, due to strain from exercise or normal household and work activities.

It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

PMS (Modes 1 and 3)

To stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

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)

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