HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES

K022917 · Home Care Technology Co., Ltd. · GXY · Mar 4, 2003 · Neurology

Device Facts

• Record ID: K022917
• Device Name: HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES
• Applicant: Home Care Technology Co., Ltd.
• Product Code: GXY · Neurology
• Decision Date: Mar 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended to be applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Device Story

Self-adhesive electrodes (FA, CA, TA, FI, TI, FR, CR, R Series) applied to patient skin; function as interface for recording physiological signals (e.g., EEG) or delivering electrical stimulation. Used in clinical or home settings; operated by healthcare professionals or patients. Device acts as passive conductive medium between skin and external monitoring or stimulation equipment. Benefits include non-invasive signal acquisition and therapeutic electrical delivery.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Self-adhesive cutaneous electrodes; conductive interface for physiological signal recording or electrical stimulation. Class II device (21 CFR 882.1320).

Indications for Use

Indicated for patients requiring cutaneous electrode application for physiological signal recording (e.g., EEG) or electrical stimulation delivery.

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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MAR 0 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Home Care Technology Co. Ltd. C/Ó: Dr. Jen, Ke-Min R.O.C. Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Re: K022917 Dated: November 30, 2002 Received: December 4, 2002

Trade/Device Name: Home Care various models of self-adhesive electrodes - FA, CA, TA, FI, TI, FR, CR, and R Series Regulation Numbers: 21 CFR 882.1320 Regulation Names: Cutaneous electrodes Regulatory Class: Class II Product Codes: GXY

Dear Dr. Jen, Ke-Min

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

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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 (301) 594-. 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.

Mark A. Mellman

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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510(k) Number:

K022917

Device Name:

Home Care various models of self-adhesive electrodes - FA, CA, TA, FI, TI, FR, CR, and R Series

Indications For Use:

Intended to be applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N Millkern

Division Si
is'on of General, Restorative
.d Neurological Devices

510(k) Number K022917