AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS

K023212 · Ag Garments · GXY · Dec 13, 2002 · Neurology

Device Facts

• Record ID: K023212
• Device Name: AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS
• Applicant: Ag Garments
• Product Code: GXY · Neurology
• Decision Date: Dec 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Electrodes intended for use as reusable (by a single patient), cutaneous, flexible, conductive garment/fabric electrodes for interface between electrical stimulators such as powered muscle stimulators, interferential devices, qalvanic devices, transcutaneous electrical nerve stimulators, etc. and a patient's skin for the delivery of electrical stimulation.

Device Story

AG Garments Conductive Electrodes are reusable, flexible, fabric-based electrodes designed for single-patient use. The device functions as an interface between external electrical stimulation devices (e.g., TENS, muscle stimulators, galvanic units) and the patient's skin. By providing a conductive path, the garment allows for the delivery of electrical stimulation to the target area. The device is intended for use in clinical or home settings under the direction of a healthcare provider. It facilitates therapeutic electrical stimulation for patients requiring such treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Flexible, conductive fabric/garment construction. Designed for cutaneous application. Reusable by a single patient. Functions as a passive conductive interface for external electrical stimulators.

Indications for Use

Indicated for single-patient use as a cutaneous, flexible, conductive interface for electrical stimulators (e.g., TENS, powered muscle stimulators, interferential, 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FC 1 3 2002

AG Garments Athena Shudde President 1762 Columbia Street San Diego, California 92101

Re: K023212

Trade/Device Name: AG Garments Conductive Electrodes Regulation Number: 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: September 25, 2002 Received: September 26, 2002

Dear Ms. Shudde:

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

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Page 2 – Ms. Athena Shudde

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.

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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Miriam C. Provost

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

Enclosure

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510(k) Number(if known): K023212

Device Name: AG GARMENTS CONDUCTIVE ELECTRODES Indications for use:

Electrodes intended for use as reusable (by a single patient), cutaneous, flexible, conductive garment/fabric electrodes for interface between electrical stimulators such as powered muscle stimulators, interferential devices, qalvanic devices, transcutaneous electrical nerve stimulators, etc. and a patient's skin for the delivery of electrical stimulation.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109

OR

Over-The-Counter Use

Miriam C. Provost

I Restorative (Optional Format 1-2-90)