Counter OTC TENS Device, Model CSD-737Z

K151279 · Counter Scientific Development (Gz), Ltd. · NUH · Dec 16, 2015 · Neurology

Device Facts

• Record ID: K151279
• Device Name: Counter OTC TENS Device, Model CSD-737Z
• Applicant: Counter Scientific Development (Gz), Ltd.
• Product Code: NUH · Neurology
• Decision Date: Dec 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities choose Manual modes A, B, C, D, F, E or Auto 4. To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household work activities choose Manual modes A, B, C, D, F, E or Auto 1 or Auto 3.. To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household work activities choose Manual modes A, B, E or Auto 1 or Auto 4. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, choose Manual modes A and C or Auto 1, Auto 2, Auto 3, or Auto 4. To be used to stimulate healthy muscles in order to improve and facilitate muscle performance choose Manual Mode A or Mode B.

Device Story

Counter OTC TENS Device (Model CSD-737Z) is a transcutaneous electrical nerve stimulator for OTC pain relief and muscle stimulation. Device delivers electrical pulses via electrodes to target areas; user selects from various manual (A-F) or automatic (1-4) stimulation modes based on intended application (pain relief or muscle performance). Operated by patient for home use. Output consists of electrical stimulation to nerves/muscles; intended to provide symptomatic relief of chronic/intractable pain, arthritis pain, and muscle strain, or to facilitate muscle performance. Device provides non-pharmacological pain management.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Transcutaneous electrical nerve stimulator (TENS). Features multiple manual and automatic stimulation modes. Operates via electrical pulse delivery to skin surface. Class II device under 21 CFR 882.5890.

Indications for Use

Indicated for temporary relief of pain associated with sore/aching muscles in back, arms, and legs due to exercise or household strain; symptomatic relief/management of chronic, intractable pain; relief of pain associated with arthritis; and stimulation of healthy muscles to improve/facilitate muscle performance. For OTC 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 16, 2015

Counter Scientific Development (GZ) Ltd % Guenter Ginsberg President Media Trade Corporation 11820 Red Hibiscus Drive Bonita Springs, Florida 34135

Re: K151279

Trade/Device Name: Counter OTC TENS Device, Model CSD-737Z Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH; NYN; NGX; GZJ Dated: November 3, 2015 Received: November 6, 2015

Dear Guenter Ginsberg:

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,

Carlos L. Pena -SD/Δ

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) K151279

Device Name Counter OTC TENS Device, Model CSD-737Z

## Indications for Use (Describe)

To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities choose Manual modes A, B, C, D, F, E or Auto 4.

To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household work activities choose Manual modes A, B, C, D, F, E or Auto 1 or Auto 3..

To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household work activities choose Manual modes A, B, E or Auto 1 or Auto 4.

To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, choose Manual modes A and C or Auto 1, Auto 2, Auto 3, or Auto 4.

To be used to stimulate healthy muscles in order to improve and facilitate muscle performance choose Manual Mode A or Mode B.

| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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