REUSABLE STIMULATING ELECTRODES

K111270 · Bio Protech, Inc. · GXY · Sep 13, 2011 · Neurology

Device Facts

• Record ID: K111270
• Device Name: REUSABLE STIMULATING ELECTRODES
• Applicant: Bio Protech, Inc.
• Product Code: GXY · Neurology
• Decision Date: Sep 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bio Protech Reusable Stimulating electrodes are intended to be used to apply electrical stimulation current to the patient's skin or to record physiological signals. Electrical stimulation current applications of these electrodes are: - Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief. a) - b) Electrical muscle stimulation (EMS) - C) Functional electrical stimulation (FES) - d) Microcurrent electrical nerve stimulation (MENS) - Interferential stimulation (IF) e) - f) Neuromuscular electrical stimulation (NMES)

Device Story

Reusable Stimulating Electrodes function as conductive interface between electrical stimulation/recording equipment and patient skin. Device applies electrical current for TENS, EMS, FES, MENS, NMES, or records physiological signals. Used in clinical or home settings under prescription. Electrodes adhere to skin to deliver therapeutic stimulation or capture bio-signals for diagnostic/monitoring purposes. Benefits include non-invasive pain management and muscle rehabilitation.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Cutaneous electrode; reusable; conductive interface for electrical stimulation or signal recording. Materials and sterilization methods consistent with standard cutaneous electrode requirements.

Indications for Use

Indicated for patients requiring electrical stimulation for pain relief (TENS), muscle stimulation (EMS, FES, NMES), microcurrent stimulation (MENS), or interferential stimulation (IF), or for recording physiological signals.

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)

{0}------------------------------------------------

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Bio Protech, Inc. c/o Ms. Judy Burton Director of U.S. Operations Advena, Ltd. 3010 Lyndon B. Johnson Freeway, 12th Floor Dallas, TX 75234

and the same of the same

SEP 1 3 2011

. . . . . .

Re: K111270

Trade/Device Name: Reusable Stimulating Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Codes: GXY Dated: July 25, 2011 Received: August 10, 2011

Dear Ms. Burton:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

{1}------------------------------------------------

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industrv/default.htm.

Sincerely yours.

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

for

Enclosure

{2}------------------------------------------------

## SECTION 4 - Indications for Use Statement

510(k) Number (if known):

K111270

Device Name: Reusable Stimulating Electrodes

## Indications for Use:

Bio Protech Reusable Stimulating electrodes are intended to be used to apply electrical stimulation current to the patient's skin or to record physiological signals.

Electrical stimulation current applications of these electrodes are:

- Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief. a)
- b) Electrical muscle stimulation (EMS)
- C) Functional electrical stimulation (FES)
- d) Microcurrent electrical nerve stimulation (MENS)
- Interferential stimulation (IF) e)
- f) Neuromuscular electrical stimulation (NMES)

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

5

t

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Page 1 of 1 |
|--|-------------|
|--|-------------|

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear,

Nose and Throat Devices

| 510(k) Number | K111278 |
|---------------|---------|
|---------------|---------|

| | 4-1 |
|--|-----|
|--|-----|