PROTENS ELECTRODE

K042301 · Bio Protech, Inc. · GXY · Sep 3, 2004 · Neurology

Device Facts

• Record ID: K042301
• Device Name: PROTENS ELECTRODE
• Applicant: Bio Protech, Inc.
• Product Code: GXY · Neurology
• Decision Date: Sep 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Bio Protech, Inc. PROTENS are designed and intended to be used with marketed transcutaneous electrical nerve stimulators (TENS). The PROTENS electrodes provide the conductive interface between the TENS generator and the patient's skin. Caution: Federal law restricts this device to sale by or on the order of a physician.

Device Story

PROTENS electrodes function as a conductive interface between a TENS generator and patient skin; facilitates delivery of electrical stimulation for nerve modulation. Device is a passive accessory used in clinical or home settings under physician prescription. No active electronic components or software; simple conductive pad design.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Cutaneous electrode; conductive interface; passive component; no energy source; no software; non-sterile or sterile (not specified); dimensions/materials not detailed in provided text.

Indications for Use

Indicated for use as a conductive interface between a TENS generator and the patient's skin for patients requiring transcutaneous electrical nerve stimulation. Prescription use only.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 3 2004

Bio Protech, Inc. C/o Mr. Ned E. Devine, Jr. Entela, Inc. 3033 Madison Avenue, SE Grand Rapids, Michigan 49548

Re: K042301

Trade/Device Name: PROTENS electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: August 25, 2004 Received: August 25, 2004

Dear Mr. Devine:

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. Ned E. Devine, Jr.

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 it you attire 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. Milken

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ____ PROTENS electrode

Indications for Use:

The Bio Protech, Inc. PROTENS are designed and intended to be used with marketed transcutaneous electrical nerve stimulators (TENS). The PROTENS electrodes provide the conductive interface between the TENS generator and the patient's skin.

Caution: Federal law restricts this device to sale by or on the order of a physician.

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 OF NEEDED)

Concurrence of CDRA, Office of Device Evaluation (ODE)

Page of

Division Sign-Off) Division of General, Restorative.

and Neurological Devices

**510(k) Number** K042301