THERMOSKIN CONDUCTIVE PADS

K030564 · United Pacific, Inc. · GXY · Sep 12, 2003 · Neurology

Device Facts

• Record ID: K030564
• Device Name: THERMOSKIN CONDUCTIVE PADS
• Applicant: United Pacific, Inc.
• Product Code: GXY · Neurology
• Decision Date: Sep 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Electrodes intend for use as re-usable (by single patient), cutaneous, flexible conductive garment / fabric electrodes for interface between electrical stimulators, such as powered muscle stimulators, interferential devices, galvanic devices, trans-cutaneous electrical nerve stimulators etc., and a patient's skin for the delivery of clectrical stimulation.

Device Story

Thermoskin Conductive Pads are flexible, fabric-based cutaneous electrodes; designed for single-patient, reusable interface between electrical stimulation devices (TENS, muscle stimulators, interferential, galvanic) and patient skin. Device functions as a conductive pathway for electrical current delivery. Used in clinical or home settings under provider guidance. Benefits include improved comfort and conformability compared to traditional rigid electrodes during electrical stimulation therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Flexible conductive garment/fabric electrode; cutaneous interface; reusable by single patient; compatible with standard electrical stimulators (TENS, galvanic, interferential).

Indications for Use

Indicated for single-patient use as a cutaneous, flexible conductive interface for electrical stimulators (e.g., TENS, powered muscle stimulators, interferential, or galvanic devices) to deliver electrical stimulation to the skin.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Submission Summary (Full Text)

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Public Health Service

SEP 1 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kevin Outred Director United Pacific, Inc. 400 Northeast Drive 20/21 Business Center, Unit F Columbia, SC 29203

Re: K030564 Trade Name: Thermoskin Conductive Pads Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: June 11, 2003

Received: June 16, 2003

Dear Mr. Outred:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Kevin Outred

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Muriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

## THERMOSKIN CONDUCTIVE PADS

Electrodes intend for use as re-usable (by single patient), cutaneous, flexible conductive garment / fabric electrodes for interface between electrical stimulators, such as powered muscle stimulators, interferential devices, galvanic devices, trans-cutaneous electrical nerve stimulators etc., and a patient's skin for the delivery of clectrical stimulation.

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030564