Conductive Gel

K221724 · Tone-A-Matic International, Inc. · GYB · Sep 23, 2022 · Neurology

Device Facts

• Record ID: K221724
• Device Name: Conductive Gel
• Applicant: Tone-A-Matic International, Inc.
• Product Code: GYB · Neurology
• Decision Date: Sep 23, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Conductive Gel is intended for use with TENS (transcutaneous electrical nerve stimulation) and EMS (electric muscle stimulation) therapy. The Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.

Device Story

Conductive gel applied to skin surface to facilitate electrical contact for TENS and EMS therapy; reduces impedance between electrode and skin; used by patients in home or clinical settings; improves electrical signal transmission for therapeutic stimulation.

Technological Characteristics

Electroconductive media; gel formulation; non-sterile; intended for topical application to skin.

Indications for Use

Indicated for use with TENS and EMS therapy to reduce impedance between external electrodes and skin. Suitable for over-the-counter use.

Regulatory Classification

Identification

Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.

Submission Summary (Full Text)

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September 23, 2022

Tone-A-Matic International Inc. Manuel Chuck Manager 145 Traders East Unit 18 Mississauga, Ont L5Z-3L3 Canada

Re: K221724

Trade/Device Name: Conductive Gel Regulation Number: 21 CFR 882.1275 Regulation Name: Electroconductive Media Regulatory Class: Class II Product Code: GYB Dated: June 27, 2022 Received: July 5, 2022

Dear Manuel Chuck:

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. Although this letter refers to your product as a device, please be aware 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-

combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Tushar Bansal, PhD Acting Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K221724

Device Name Conductive Gel

Indications for Use (Describe)

The Conductive Gel is intended for use with TENS (transcutaneous electrical nerve stimulation) and EMS (electric muscle stimulation) therapy. The Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.

| 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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