MANTRA ELECTRODE

K041902 · Mantra Intl. (Hk) , Ltd. · GXY · Sep 22, 2004 · Neurology

Device Facts

• Record ID: K041902
• Device Name: MANTRA ELECTRODE
• Applicant: Mantra Intl. (Hk) , Ltd.
• Product Code: GXY · Neurology
• Decision Date: Sep 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Mantra Electrode is intended to be used with Transcutaneous Nerve Stimulator and Electronic Muscle Stimulator Units.

Device Story

Mantra Electrode is a multi-layer cutaneous electrode designed for use with Transcutaneous Nerve Stimulator (TENS) and Electronic Muscle Stimulator (EMS) units. The device consists of a hydrogel layer, a conducting film, and a non-woven backing material. It is available with various connector types, including snap-type lead wires, button connectors, and tab-type connectors. The electrode is applied to the patient's skin to facilitate the delivery of electrical stimulation from the stimulator unit. It functions as a passive interface between the stimulator and the patient's body. The device is intended for use in clinical or home settings as prescribed by a healthcare provider. It does not contain active electronic components or software.

Clinical Evidence

Bench testing only. Biocompatibility established.

Technological Characteristics

Multi-layer structure comprising hydrogel, conducting film, and non-woven backing. Connectors include snap-type, button, and tab-type. Passive cutaneous electrode. No software or active energy source.

Indications for Use

Indicated for use with Transcutaneous Nerve Stimulator (TENS) and Electronic Muscle Stimulator (EMS) units for patients requiring electrical stimulation therapy.

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

• Uni-Patch Electrode Model Re-Ply (K983097)

Submission Summary (Full Text)

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Mantra International Ltd. P.O. Box 800 Oxford, OH 45056 Tel: [phone] FAX: [phone]

SEP 2 2 2004

## 510(k) Summary

| Contact Person: | Brent Reider |
|----------------------|----------------------|
| Date of Preparation: | July 7, 2004 |
| Trade Name: | Mantra Electrode |
| Common Name: | Cutaneous electrode |
| Classification Name: | electrode, cutaneous |
| Product Code: | GXY |
| Regulation Class: | 2 |
| Regulation Number: | 882.1320 |

Description of the Device: - The Mantra Electrode is a multi-layer structure containing conducting material and one of several types of connectors.

The Mantra Electrode is intended to be used with Transcutaneous Intended Use: Nerve Stimulator and Electronic Muscle Stimulator Units.

Technical Characteristics: The technical characteristics of the Mantra Electrode are identical to the predicate device. The electrode is a multi-layer structure consisting of a layer of hydrogel, conducting film and a non-woven backing material. Various connectors can be used with the electrodes: (1) snap type lead wires for button connector type electrodes, (2) button type clectrodes, and (3) tab type electrodes.

This product is substantially equivalent to the Uni-Substantial Equivalence: Patch Electrode Model Re-Ply® manufactured by Uni-Patch, Inc., Wabasha, Minnesota (K983097).

Substantial equivalence is based upon:

- . The Mantra Electrode has the same indications for use as the predicate device.

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- The Mantra Electrode has equivalent technological characteristics and instructions . for use, as compared to the predicate device.
- The device meets the mandatory performance standards. .

:

- The biocompatibility of the electrodes has been established. .

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 2004

Mantra International Ltd. C/o Mr. Robert B. Spertell RBS Technologies, LLC 10235 Glade Avenue Chatsworth, California 91311

Re: K041902

Trade/Device Name: Mantra Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: June 25, 2004 Received: July 14, 2004

Dear Mr. Spertell:

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 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.

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Page 2 - Mr. Robert B. Spertell

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 Office of Compliance 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 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 A. Wilkerson

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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## Indications for Use

K 041902 510(k) Number (if known):

Device Name: Mantra Electrode

The Mantra Electrode is intended to be used with Transcutaneous Indications for Use: Nerve Stimulator and Electronic Muscle Stimulator Units.

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

Over-The-Counter-Use (21 CFR 807 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 A. Mellers

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

**510(k) Number** K041902