GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM

K092546 · Gmdasz Manufacturing Co., Ltd. · GXY · Dec 18, 2009 · Neurology

Device Facts

• Record ID: K092546
• Device Name: GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM
• Applicant: Gmdasz Manufacturing Co., Ltd.
• Product Code: GXY · Neurology
• Decision Date: Dec 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GMDASZ TENS Electrodes are intended for use as a reusable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. GMDASZ's reusable electrodes are designed and intended to be used with marketed, Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation). The electrotherapy electrodes are intended to be used to apply electrical stimulation current to the patient's skin.

Device Story

GMDASZ TENS Electrodes are multi-layer, flexible, reusable cutaneous electrodes; function as conductive interface between patient skin and electrical stimulators (TENS, EMS, IF, PGF). Device consists of insulating backing (fabric/foam), conductive plastic film, and biocompatible self-adhesive conductive hydrogel; includes PET protective liner. Connects to stimulators via lead wire with standard .080" recessed female terminal. Used in clinical or home settings; operated by patients or clinicians. Device applies electrical stimulation current to skin; adhesive hydrogel eliminates need for external securing materials. Insulated outer jacket prevents contact with hazardous voltages. Benefits include reusable, convenient application of electrotherapy.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Multi-layer flexible structure: insulating backing (fabric/foam), conductive plastic film, biocompatible self-adhesive conductive hydrogel, PET liner. Connectivity: standard .080" recessed female terminal. Complies with IEC60601-1 Subclause 56 3(c) and 21 CFR Part 898. Passive device; no software or active electronic components.

Indications for Use

Indicated for use as a conductive interface between patient skin and electrical stimulators (TENS, EMS, IF, or PGF) to apply electrical stimulation current. Intended for single-patient, multiple-application use.

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

• ValuTrode (K970426)
• EZ-Stik (K050469)

Submission Summary (Full Text)

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## 510(k) Summary

DEC 1 8 2009

510(k): k092546

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: July 18, 2009

1. Company and Correspondent making the submission:

Name - GMDASZ Manufacturing Co., Ltd.

Address – E-1308, Xihaimingzhu Building,

Nanshan District, Shenzhen City

Guangdong Province, China

Telephone - [phone]

Fax – [phone]

Contact - Xiangjie Zhang

Email – [e-mail]

2. Device :

Trade/proprietary name: GMDASZ TENS Electrodes

Common Name : Cutaneous electrode

Classification Name : electrode, cutaneous

Predicate Devices:

| Predicate<br>Model | Manufacturer | K Number | Submitted Device |
|--------------------|---------------------------------------|----------|------------------------|
| ValuTrode | Axelgaad<br>Manufacturing Co.,<br>Ltd | K970426 | GMDASZ TENS Electrodes |
| EZ-Stik | NAlmco, Inc. | K050469 | GMDASZ TENS Electrodes |

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- 3. Classifications Names & Citations : 21CFR 882.1320, GXY, Cutaneous Electrode
## 4. Description :

4.1 General

GMDASZ TENS electrodes are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application (Refer to attached BOM):

First layer—insulating backing material: Fabric, foam or tan fabric Second layer—Conductive plastic film Third Layer – Biocompatible self-adhesive conductive hydro gel Protective liner-PET

The electrodes are designed for single-patient/ multiple application use. Because of the adhesive nature of the biocompatible conductive hydro gel, no securing materials are required to secure the device to the patient's skin. The electrode is connected to the stimulating device by lead wire, with a standard .080" recessed female terminal with insulating outer jacket. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages as required in IEC60601-1 Subclause 56 3(c). Wire assembly is incompliance with FDA performance standard 21 CFR Part 898.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, abstract style, with thick, curved lines forming its body and wings. The text is in all caps and is arranged to follow the curve of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring. MD 20993-0002

GMDASZ Manufacturing Co., LTD c/o Mr. Charlie Mack Principal Engineer International Regulatory Consultants, LLC 77325 Joyce Way Echo, Oregon 97826

Re: K092546

Trade/Device Name: GMDASZ TENS ELECTRODES, Models CWN1005, CWN1007, CWN2505, CWN2509, ACWN1005, ACWN1007, ACWN2505, ACWN2509

DEC 1 8 2009

Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: II Product Code: GXY Dated: November 28, 2009 Received: December 7, 2009

Dear Mr. Mack:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html

Sincerely yours,

Kesia Alexander for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological. and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

1092546 510(k) Number (if known):

Device Name: GMDASZ TENS Electrodes

Indications for Use:

The GMDASZ TENS Electrodes are intended for use as a reusable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. GMDASZ's reusable electrodes are designed and intended to be used with marketed, Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation).

The electrotherapy electrodes are intended to be used to apply electrical stimulation current to the patient's skin.

イ Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number k092546