LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL

K012463 · Everyway Medical Instruments Co.,Ltd · GXY · Feb 5, 2002 · Neurology

Device Facts

• Record ID: K012463
• Device Name: LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL
• Applicant: Everyway Medical Instruments Co.,Ltd
• Product Code: GXY · Neurology
• Decision Date: Feb 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lifecare electrodes are intended to be used with transcutaneous neurostimulation devices. Some common types of neurostimulation devices include, but are not limited to, TENS devices and powered muscle stimulation devices. Transcutaneous neurostimulation electrodes are passive devices serving as an interface between a patinet's skin and a neurostimulation device.

Device Story

Lifecare Neurostimulation Electrodes are passive interface components designed for use with transcutaneous neurostimulation devices (e.g., TENS, powered muscle stimulators). The electrodes adhere to the patient's skin to conduct electrical stimulation from the device to the underlying tissue. They are available in various shapes and sizes (square, round, oval, rectangular). The device is intended for use in clinical or home settings under the direction of a healthcare provider or by the patient as prescribed. By providing a stable electrical interface, the electrodes facilitate the delivery of neurostimulation therapy, which may assist in pain management or muscle stimulation.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Passive cutaneous electrode; various geometries (square, round, oval, rectangular); interface for transcutaneous neurostimulation; non-sterile or sterile (not specified); no active electronic components or software.

Indications for Use

Indicated for use as a passive interface between a patient's skin and transcutaneous neurostimulation devices, including TENS and powered muscle stimulators.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 0 5 2002

Mr. Robert Tu Everyway Medical Instruments Co., Ltd. 3 Fl., No. 5, Lane 155, Peishen Rd., Sec. 3 Shen Keng Hsiang, Taipei Hsien 222, Taiwan, R.O.C.

Re: K012463

Trade/Device Name: Lifecare: 5 x 5 CM Square, 4 x 4 CM Square, 5 CM Round, 7.5 CM Round, 4 x 6 CM Oval, 5 x 10 CM Oval, 4 x 8 CM Rectangle,

5 x 10 CM Rectangle Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: November 8, 2001 Received: November 13, 2001

Dear Mr. Tu:

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

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Page 2 - Mr. Tu

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 N. Millano

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 (if known): K012463

Device Name:__Lifecare Neurostimulation Electrode

Indications For Use:

The Lifecare electrodes are intended to be used with transcutaneous neurostimulation devices. Some common types of neurostimulation devices include, but are not limited to, TENS devices and powered muscle stimulation devices. Transcutaneous neurostimulation electrodes are passive devices serving as an interface between a patinet's skin and a neurostimulation device.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

KO12463

Marlis N. Millhurn

(Optional Format 3-10-98)

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

510(k) Number -