TENS/FES/NMES ELECTRODES

K983097 · Uni-Patch, Inc. · GXY · Sep 17, 1999 · Neurology

Device Facts

• Record ID: K983097
• Device Name: TENS/FES/NMES ELECTRODES
• Applicant: Uni-Patch, Inc.
• Product Code: GXY · Neurology
• Decision Date: Sep 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The electrode is used in conjunction with electrical stimulating therapy for the symptomatic relief and management of chronic pain or some types of acute pain, muscle stimulation therapy for the relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, and maintaining or increasing range of motion.

Device Story

Device consists of conductive hydrogel, lead wire, and non-conductive cloth backing; functions as interface between TENS/FES/NMES stimulation device and patient skin. Used for pain management and muscle therapy. Operated by patient in home or clinical setting. Conducts electrical current from stimulator to skin to achieve therapeutic effects like muscle relaxation or pain relief. Benefit includes non-invasive symptomatic relief and physical therapy support.

Clinical Evidence

Bench testing only. Effectiveness established via comparative impedance testing at 1K-Hz against predicate devices. Biocompatibility of conductive hydrogel confirmed via skin sensitivity testing per Tripartite Biocompatability Guidance.

Technological Characteristics

Components: conductive hydrogel, lead wire, non-conductive cloth backing with printed conductor. Sensing/Actuation: passive electrical conduction. Connectivity: wired connection to external TENS/FES/NMES stimulator. Biocompatibility: tested per Tripartite Biocompatability Guidance.

Indications for Use

Indicated for patients requiring electrical stimulation therapy for chronic or acute pain management, muscle spasm relaxation, prevention/retardation of disuse atrophy, local blood circulation improvement, and range of motion maintenance. For single patient, over-the-counter 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

• Tantone Multi-Day 633 TENS Electrode (K871222)
• Reusable TENS Paravertebral Pad 641 Back Electrode (K901575A)

Reference Devices

• Medtronic ComfortEase (K851303)
• 3M Myocare Muscle Stimulation Electrodes (K905539)

Submission Summary (Full Text)

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SEP 1 7 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Keith J. Geolat Manager of Quality Assurance and Regulatory Affairs Uni-Patch Medical Supplies Post Office. Box 271 1313 West Grant Boulevard Wabasha, Minnesota 55981

Re: K983097

Trade Name: TENS/FES/NMES Electrodes Regulatory Class: II Product Code: GXY Dated: June 16, 1999 Received: June 22, 1999

Dear Mr. Geolat:

We have reviewed your Section 510(k) notification of intent to market the device referenced above we have reviewed your Section 170(k) notically equivalent (for the indications for use stated in
and we have determined the device is substantially equivalent (for the snatem and we have determined the device is substantially courtered (on May 28, 1976, the enactment the enclosure) to devices marketed in microate donices that have been reclassified in accordance date of the Medical Device Antendinents, or to ac need and Act (Act). You may, therefore, market answere of with the provisions of the rederal rood, Drug, aisons of the Act. The general controls provisions of
the device, subject to the general controls provisions of the Act. The g the device, subject to the general concess provinsion, listing of devices, good manufacturing are Act merade requirements sions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premaket II your device is classifica (see above) into only in the sixisting major regulations affecting your Approval), It may be subject to such additions, Title 21, Parts 800 to 895. A substantially
device can be found in the Code of Federal Regulations, Title 21, Canada supportu device can be found in the Code of Pederal Reguith the current Good Manufacturing Practice equirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requirement, as set form in the Quality Bystein reguliare (QS) inspections, the Food and Drug
regulation (21 CFR Part 820) and that, through periodic (QS) inspections with th regulation (FDA) will verify such assumptions. Failure to comply with the GMP regulation Administration (1127) will vertify such assumpliems announcements concerners concerning may result in regulatory action: "In addition, a be a this response to your premarket notification your device in the Federal Kegister. Ticaso note: Intel rections 531 through 542 of the Act
submission does not affect any obligation you might have under ather Foderal laws submission does not affect any other Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to begin marketing your device to a legally marketed notification. The FDA Inding of Substantial equivalence on Jour device to proceed to the market.

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Page 2 - Mr. Keith J. Geolat

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and IT you desire specific data or never your ostic devices), please contact the Office of Compliance at additionally 007.10 for in This are nestions on the promotion and advertising of your device, [phone]. Tructionally, 101 quest 21.01.1594-4639. Also, please note the regulation
[phone]. Traditional [phone]. Also, please note the cegalation prease contact the Office of Compitance as (2011) 11:10 PM 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small information on your responsionnies ander the rise not not [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

[signature]

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

P

Enclosure

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Page 1 of 1

K962332 510(k) Number (if known):

TENS / FES / NMES Electrodes Device Name:

Indications For Use:

To conduct electrical stimulation to a patient's skin.

Single patient use.

Repositionable, self-adhering.

Over the counter use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

(Optional Format 1-2-96)

Division Sign Off

(Division Sign-Off) Division of General Restorative Device 510(k) Number

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#### September 9, 1999

## 510(k) Summary

# 1) Establishment Address, Contact, and Registration Number:

Uni-Patch 1313 West Grant Blvd. Wabasha, MN 55981

Registration Number: 2183164

Contact: Keith Geolat - Manager of Quality Assurance & Regulatory Affairs Phone: [phone]

## 2) Device Name

- A. Classification: Electrode, Cutaneous, Classification Number: 84 GXY Class II
- B. Common/Usual: TENS, FES, NMES Stimulating Electrodes

## 3) Substantial Equivalence

The Uni-Patch TENS, FES, and NMES Electrodes with conductive gel are substantially equivalent to electrodes that have already been found to be substantially equivalent through the 510(k) premarket notification process. Uni-Patch currently manufactures and distributes the following electrodes carrying the same indication for use.

Tantone Multi-Day 633 TENS Electrode - K871222 Reusable TENS Paravertebral Pad 641 Back Electrode - K901575A

Uni-Patch proposes to manufacture and market this electrode family with conductive gel using similar designs and compositions of previously annoved devices.

## 4) Device Description

The device provides a means for establishing electrical contact between the lead connected to a TENS, FES, or NMES stimulation device and the skin. The device consists of conductive hydrogel, a conductive lead wire, a non-conductive cloth backing material with a printed conductor on the side contacting the hydrogel.

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### 5) Intended Use

The electrode is used in conjunction with electrical stimulating therapy for the symptomatic relief and management of chronic pain or some types of acute pain, muscle stimulation therapy for the relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, and maintaining or increasing range of motion.

## 6) Technological Characteristics Comparison

Uni-Patch has compared our electrode to other legally marketed electrodes that carry the TENS and NMES indication; the Medtronic ComfortEase (K851303), and the 3M Myocare (K905539) Muscle Stimulation Electrodes.

There are no published performance standards for TENS, FES, or NMES electrodes, so Uni-Patch used impedance levels as the criteria for effectiveness testing. When measuring the electrode impedance, driven at 1K-Hz, we have determined that the electrode impedance values were comparable to all the legally marketed electrodes identified above. (See attached data.)

i Additionally, the Hydrogel used in the Uni-Patch electrodes has passed the required skin sensitivity testing criteria as specified in the Tripartite Biocompatability Guidance for Medical Devices. The Hydrogel used in Uni-Patch's electrodes has been used extensively throughout the industry for over fifteen years.

Based on this testing Uni-Patch considers its TENS, FES, NMES stimulating Bacted on as safe and effective as the Medtronic ComfortEase and the 3M Myocare Muscle Stimulation electrodes.