COM-PATCH

K012140 · Apex Medical Corp. · GXY · Oct 5, 2001 · Neurology

Device Facts

• Record ID: K012140
• Device Name: COM-PATCH
• Applicant: Apex Medical Corp.
• Product Code: GXY · Neurology
• Decision Date: Oct 5, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Apex self-adhesive electrodes are intended to be used in TENS (Transcutaneous Electrical Stimulation) and NMES (NeuroMuscular Electrical Stimulation) applications.

Device Story

Apex self-adhesive electrodes function as conductive interfaces between TENS/NMES stimulation devices and patient skin. Electrodes deliver electrical current from stimulator to target tissue; used in clinical or home settings under prescription. Device consists of adhesive conductive pads; facilitates therapeutic electrical stimulation for pain management or muscle stimulation. No active electronic components; passive interface.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Cutaneous electrode; self-adhesive; conductive material; passive interface; dimensions/form factor vary by model (AP-0981201, AP-0981203, AP-0981208, AP-0981209).

Indications for Use

Indicated for use in TENS and NMES applications for patients requiring transcutaneous electrical stimulation or neuromuscular electrical stimulation.

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

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wings, all rendered in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 5 2001

Mr. Alan Chang Apex Medical Corp. 10th Fl., No. 31, Lane 169, Kang Ning St. His Chih Chen, Taipei Hsien, 221, Taiwan, R.O.C.

Re: K012140

> Trade/Device Name: Com-Patch, Self Adhesive Electrodes Models: AP-0981201, AP-0981203, AP-0981208, and AP-0981209 Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Codes: GXY Dated: July 3, 2001 Received: July 10, 2001

Dear Mr. Chang:

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.

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Page 2 - Mr. Chang

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.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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.

Marl n Milken

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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Page _ 1 of _ 1

012 510(k) Number : Device Name : Apex self adhesive electrodes

Indications For Use:

Apex self-adhesive electrodes are intended to be used in TENS (Transcutaneous Electrical Stimulation) and NMES (NeuroMuscular Electrical Stimulation) applications.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | x | OR | Over-The-Counter-Use____ |
|-------------------------------------------------------------------------------------|---------|----|--------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |
| | | | |
| <div align="center">(Division Sign-Off)</div> | | | |
| <div align="center">Division of General, Restorative and Neurological Devices</div> | | | |
| 510(k) Number | K012190 | | |