EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220

K961141 · Uni-Patch, Inc. · GXY · May 10, 1996 · Neurology

Device Facts

• Record ID: K961141
• Device Name: EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220
• Applicant: Uni-Patch, Inc.
• Product Code: GXY · Neurology
• Decision Date: May 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Device Story

Repositionable electrodes for TENS and NMS/FES therapy; utilize RG-60 Series conductive gel for skin adhesion; interface between electrical stimulator and patient skin; used in clinical or home settings; applied by patients or clinicians; function by delivering electrical current to underlying nerves/muscles; effectiveness verified via impedance measurement at 1K-Hz; biocompatible design ensures safe short-term skin contact.

Clinical Evidence

Bench testing only. No clinical data. Effectiveness established by comparing electrode impedance levels at 1K-Hz against predicate devices. Safety established by biocompatibility testing of RG-60 Series gel, including Cytotoxicity, Buehler Patch Test (Dermal Sensitization), Repeat Insult Patch Test, and Primary Skin Irritation Test.

Technological Characteristics

Repositionable cutaneous electrodes; RG-60 Series conductive gel; impedance-based performance; biocompatible materials per Tripartite Biocompatibility Guidance.

Indications for Use

Indicated for patients requiring Transcutaneous Electrical Nerve Stimulation (TENS) or Muscle Stimulation (NMS/FES) 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

• Medtronic Comfort-Ease TENS & Neuro-Muscular Stimulation Electrodes
• 3M Myocare Muscle Stimulation Electrodes
• LMI TENS/EMS Electrodes

Submission Summary (Full Text)

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UNI-PATCH Medical Supplies

K961141

MAY 10 1996

# 510(k) Premarket Notification
Repositionable TENS and EMS Electrodes
with RG-60 Series Gel

## SUMMARY OF SAFETY AND EFFECTIVENESS

Uni-Patch considers their Transcutaneous Electrical Nerve (TENS) and Muscle Stimulation (NMS/FES) electrodes to be as safe and effective as the Medtronic, Comfort-Ease®, TENS & Neuro-Muscular Stimulation Electrodes, the 3M, Myocare®, Muscle Stimulation Electrodes, and the LMI TENS/EMS Electrodes 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 1K-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 (NMS/FES) to be as safe and effective as the Medtronic, Comfort-Ease®, 3M, Myocare®, and the LMI TENS/EMS Electrodes.

March 08, 1996

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