SELF-ADHESIVE ELECTRODES

• K Number: K080276
• Device Name: SELF-ADHESIVE ELECTRODES
• Manufacturer: CATHAY HEALTHCARE EQUIPMENT MANUFACTURING, INC
• Date Cleared: 2008-08-04 ( 182 days)
• Product Code: GXY
• Regulation Number: 882.1320

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 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.

Predicate Devices

K020735, K070612

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a passive electrode for electrical stimulation and does not mention any AI or ML capabilities.

Therapeutic

No
This device is an electrode, which is a component used with a TENS device, but it is not a therapeutic device itself. Its function is to apply electrical stimulation or record physiological signals, not to provide therapy directly.

Diagnostic

No.
The device is described as an electrotherapy electrode intended to apply electrical stimulation or record physiological signals, and it connects to a TENS device. There is no mention of diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "electrotherapy electrode" which is a physical hardware component. It also mentions connecting to a TENS device via lead wires, further indicating a hardware-based device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to "apply electrical stimulation current to the patient's skin or record physiological signals." This involves interacting directly with the patient's body (in vivo) for therapeutic or diagnostic purposes, not analyzing samples taken from the body (in vitro).
• Device Description: The description focuses on the physical characteristics of the electrode and its connection to a TENS device, which is used for electrical stimulation on the body.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.

Therefore, this device falls under the category of a medical device used for electrical stimulation and/or physiological signal recording, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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

Product codes

GXY

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's skin

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not Found

Key Metrics

Not Found

Predicate Device(s)

K020735, K070612

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

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

1

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
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;
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
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
irritation and delayed-type hypersensitivity ISO 10993-10:2002

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

2

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

3

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

4

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)

!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Mark M. Milliken

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

510(k) Number