SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY

K962910 · Uni-Patch, Inc. · GZJ · Sep 5, 1996 · Neurology

Device Facts

• Record ID: K962910
• Device Name: SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY
• Applicant: Uni-Patch, Inc.
• Product Code: GZJ · Neurology
• Decision Date: Sep 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Uni-Patch considers their Transcutaneous Electrical Nerve Stimulation (TENS) and Muscle Stimulation (NMES/FES) Electrodes to be as safe and effective as the Axelgaard Manufacturing Company Pals® Plus Reusable Neurostimulation Electrode and the LMI Spec T.E.N.S. Repositionable Pin-Type TENS Electrode (K894042A) with Promeon RG-60 Series gel of which were previously found to be substantially equivalent via a 510(k) Premarket Notification.

Device Story

Repositionable electrodes for TENS, NMES, and FES; utilize RG-60 series conductive gel for skin adhesion; interface between electrical stimulator and patient skin; used in clinical or home settings; operated by patients or clinicians; function by delivering electrical current to target tissue; effectiveness verified via impedance measurement at 1K-Hz; safety verified via biocompatibility testing of gel.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per Tripartite Biocompatibility Guidance (Cytotoxicity, Buehler Patch Test, Repeat Insult Patch Test, Primary Skin Irritation). Effectiveness established via comparative impedance testing at 1K-Hz against predicate electrodes.

Technological Characteristics

Repositionable cutaneous electrodes; RG-60 series conductive gel; impedance-based performance; short-term skin contact; biocompatibility per Tripartite Guidance.

Indications for Use

Indicated for use as electrodes for Transcutaneous Electrical Nerve Stimulation (TENS) and Neuromuscular Electrical Stimulation (NMES/FES) for patients requiring electrical stimulation therapy.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• Axelgaard Manufacturing Company Pals® Plus Reusable Neurostimulation Electrode
• LMI Spec T.E.N.S. Repositionable Pin-Type TENS Electrode (K894042A)

Submission Summary (Full Text)

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UNI-PATCH Medical Supplies

SEP 5 1996

K962910

510(k) Premarket Notification Amendment to 510(k) Repositionable TENS, NMES, and FES Electrodes

# SUMMARY OF SAFETY AND EFFECTIVENESS

Uni-Patch considers their Transcutaneous Electrical Nerve Stimulation (TENS) and Muscle Stimulation (NMES/FES) Electrodes to be as safe and effective as the Axelgaard Manufacturing Company Pals® Plus Reusable Neurostimulation Electrode and the LMI Spec T.E.N.S. Repositionable Pin-Type TENS Electrode (K894042A) with Promeon RG-60 Series gel of which were previously found to be substantially equivalent via a 510(k) Premarket Notification. The safety issues analyzed were skin irritation. The effectiveness of the electrodes was determined by comparing impedance levels.

The first safety issue was to determine if the gel, which is used to adhere the electrode to the skin, would cause any skin irritation. The RG-60 Series gels used in this family of electrodes have passed the required skin sensitivity testing criteria as specified in the Tripartite Biocompatibility Guidance For Medical Devices. These tests include Cytotoxicity, Dermal Sensitization Study (Buehler Patch Test), Repeat Insult Patch Test, and Primary Skin Irritation Test. The gels used in the Uni-Patch TENS and Muscle Stimulation Electrodes have already been used in cutaneous electrodes manufactured by Uni-Patch. Therefore, Uni-Patch considers the RG-60 Series gels used in the manufacturing of their TENS and Muscle Stimulation Electrodes to be acceptable for short-term contact with the skin.

There are no published performance standards for TENS or Muscle Stimulation Electrodes, so Uni-Patch used impedance levels as the criteria for effectiveness testing. When measuring the electrodes impedance, driven at $1\mathrm{K}-\mathrm{Hz}$, we have determined that the electrode impedance values were comparable to all the electrodes tested.

Therefore, Uni-Patch considers its TENS and Muscle Stimulation Electrodes (NMES/FES) to be as safe and effective as the above mentioned TENS/NMES Electrodes.

July 18, 1996

P.O. Box 271 1313 West Grant Blvd. Wabasha, MN 55981-0271

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