EVERLIFE

K050788 · Everlife Medical Instrument Co., Ltd. · GXY · May 13, 2005 · Neurology

Device Facts

• Record ID: K050788
• Device Name: EVERLIFE
• Applicant: Everlife Medical Instrument Co., Ltd.
• Product Code: GXY · Neurology
• Decision Date: May 13, 2005
• 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

AP series self-adhesive electrodes; applied directly to patient skin. Function as interface for recording physiological signals (EEG, ECG, EMG) or delivering electrical stimulation (TENS, muscle stimulation). Used in clinical or home settings. Healthcare providers or patients apply electrodes to skin surface; device facilitates electrical contact between skin and external monitoring or stimulation equipment. Benefit includes reliable signal acquisition and effective electrical therapy delivery through maintained impedance levels.

Clinical Evidence

No clinical data. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (skin irritation and sensitization).

Technological Characteristics

Self-adhesive electrodes; conductive gel/film interface. Biocompatibility compliant with ISO 10993-5 and ISO 10993-10. Passive electrical interface.

Indications for Use

Indicated for patients requiring physiological signal recording (e.g., EEG) or electrical stimulation (e.g., ECG, EMG, TENS, muscle 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.

Predicate Devices

• HOME CARE Various Models of Self-Adhesive Electrodes (K022917)

Submission Summary (Full Text)

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## 5. 510(K) STATEMENT

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## MAY 1 9 2005

## 510(k) SUMMARY "

Submitter's Name: EVERLIFE Medical Instrument Co., Ltd. No. 58, Fu-Chiun Street, Hsin Chu City, 30067, Taiwan, ROC

Date summary prepared:

March 18, 2005

Device Name:

EVERLIFE, Various Models of Self Adhesive Electrodes, Proprietary Name: AP series Self Adhesive Electrodes Common or Usual Name:

Classification Name:

21 CFR 882.1320

GXY, Class II

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.

Biocompatibility Testing:

- Cytotoxicity study ISO 10993-5 .
- Skin irritation study ISO 10993-10
- Skin sensitization study ISO 10993-10

Legally marketed device for substantial equivalence comparison:

HOME CARE Various Models of Self-Adhesive Electrodes, K022917

Summary for substantial equivalence comparison:

The intended uses for the two devices are almost the same, because the new device can also be used for EEG, ECG, EMG, TENS, and Muscle stimulation cases. Though the gel ingredients or the conductive films for the two devices may be different, the effect of impedance levels for the intended situations is assured for both of the devices, and the safety and effectiveness hazards are not present, and they are considered to be substantially equivalent.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 2005

Everlife Medical Instrument Co., Ltd. C/o: Dr. Jen, Ke-Min ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City China (Taiwan) 300

Re: K050788

Trade/Device Name: EVERLIFE, Various Models of Self Adhesive Electrodes, AP series Regulation Numbers: 21 CFR 882.1320 Regulation Names: Cutaneous Electrode Regulatory Class: II Product Code: GXY Dated: March 18, 2005 Received: March 28, 2005

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 for association 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, de rios mat have 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 r ou mayy are a 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 may or saily of 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 I loase oc advised that rermination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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 (21 CFR Part 820); and if applicable, the electronic forth in adiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Dr. Jen, Ke-Min

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and in yourse finding of substantial equivalence of your device to a legally premaired predicated. The 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 If you desire specific darroliance 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 other general micronational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Miriam Provost, Ph.D. Acting 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

State of the States

510 (K) Number (If Known ):___________________________________________________________________________________________________________________________________________________

Device Name: EVERLIFE, Various Models of Self Adhesive Electrodes, AP series 1

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. ---

| Prescription Use | AND/OR | Over-The-Counter Use | √ |
|-----------------------------|--------|------------------------|---|
| (Part 21 CFR 801 Subpart D) | | (21 CFR 807 Subpart C) | |

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

Division of General, Restorative, and Neurological Devices

Concurrence of CDRH, Office of Device Evaluation (ODE)

| 510(k) Number | K050788 |
|---------------|---------|
|---------------|---------|

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