SELF-ADHESIVE ELECTRODES

K080276 · Cathay Health Care Equipment Manufacturing, Inc. · GXY · Aug 4, 2008 · Neurology

Device Facts

• Record ID: K080276
• Device Name: SELF-ADHESIVE ELECTRODES
• Applicant: Cathay Health Care Equipment Manufacturing, Inc.
• Product Code: GXY · Neurology
• Decision Date: Aug 4, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The electrotherapy electrodes are intended to be used to apply electrical stimulation current to the patient's skin or record physiological signals

Device Story

Self-adhesive electrodes feature high-density carbon mesh for uniform current distribution. Device connects to TENS units via single or twin lead wires. Used in clinical or home settings to apply electrical stimulation to skin or record physiological signals. Output is electrical current delivery or signal acquisition. Benefits include non-invasive therapy delivery and signal monitoring.

Clinical Evidence

No clinical data. Safety and performance verified via bench testing, analysis, and comparison to predicate devices.

Technological Characteristics

High-density carbon mesh electrode; single or twin lead wire connectivity. Complies with ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/hypersensitivity).

Indications for Use

Indicated for patients requiring electrical stimulation therapy or physiological signal recording via cutaneous electrodes.

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

• SOF-PACH Reusable Neurostimulation Electrodes (K020735)
• TOP-RANK ADHESIVE ELECTRODE (K070612)

Submission Summary (Full Text)

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Koro276

## 510(K) SUMMARY

AUG - 4 2008

[as required by 807.92(c)]

- A. 510k Number:
- B. Applicant:

Company name: Cathay healthcare equipment manufacturing. Inc Address: Taoyuan Village,Changtang Town, Shangyu City, Zhejiang Province, China Tel: [phone] Fax: [phone]

- C. Proprietary and Established Names: Cathay healthcare equipment manufacturing. Inc
- D. Regulatory Information -Product name: Self-Adhesive electrodes

-Classification: Class 2

-Product cord : GXY

-Regulation Number : 882.1320

- E. Intended use
The electrotherapy electrodes are intended to be used to apply electrical stimulation current to the patient's skin or record physiological signals

- F. Device Description
This type of electrode features a high density carbon mesh that evenly distributes current throughout the electrode surface. It connects to a TENS device through single or twin lead wire. Various standard sizes can be chosen. Any custom design can also be manufactured.

- G. Substantial Equivalence Information
- 1. Predicate Device K020735, K070612

-SOF-PACH Reusable Neurostimulation Electrodes/ TOP-RANK ADHESIVE ELECTRODE -Classification : Class 2

-Product cord : GXY

-Requlation Number : 882.1320

2. Comparison with predicate

From the above clinical evidence, we can conclude that Clinical evidence is

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demonstrated by way of

- · Comparison chart of predicate device
- . Experience from previous use
- o Testing reports, analysis

Therefore, we need not perform clinical investigation.

And, the safety and performance of Adhesive Electrodes is verified.

Based on the above, we conclude that the Adhesive Electrodes are substantially equivalent to the marketed predicate device, and do not raise any new issues of safety or effectiveness.

## H. Standard / Guidance Document Referenced (if applicable)

| 1) | ISO 9001 | 2000 | Quality management system -requirements |
|----|-----------------|------|------------------------------------------------------------------------------------------------------------------------------------|
| 2) | EN ISO 14971 | 2001 | Medical devices — Application of risk<br>management to medical devices |
| 3) | EN 980 | 2003 | Graphic Symbols for use in the labeling of medical device |
| 4) | EN 1041 | 1998 | Terminology, Symbols and Information with Medical Devices;<br>Information supplied by the manufacturer with medical devices |
| 5) | EN ISO 10993-5 | 1999 | Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro<br>Cytotoxicity ISO 10993-5:1999; Supersedes EN 30993-5:1994 |
| 6) | EN ISO 10993-10 | 2002 | Biological evaluation of medical devices - Part 10: Tests for<br>irritation and delayed-type hypersensitivity ISO 10993-10:2002 |

- Performance Characteristics (If/when applicable) ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
- 1. See the Exhibits.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, to the right. Encircling the caduceus is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cathay Healthcare Equipment Manufacturing, Inc. % Pats Corporation Mr. Brandon Choi Representative

Flemington Court, Suite 155 La Mirada, California 90638

Re: K080276

> Trade/Device Name: Self-Adhesive Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: July 24, 2008 Received: July 29, 2008

Dear Mr. Choi:

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

AUG - 4 2008

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Page 2 - Mr. Brandon Choi

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Mark N. Millican

Mark N. Melkerson 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

510(k) Number (if known):

Device Name: SELF-ADHESIVE ELECTRODES

Indications For Use: The electrotherapy electrodes are intended to be used to apply electrical stimulation current to the patient's skin or record physiological signals

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Mark M. Milliken

(Division Sign (Division Sign-off General, Restorative, Division of of Call Devices

510(k) Number