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SOF-PACH™ Reusable Cutaneous Neurostimulation Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. SOF-PACH™ Reusable Electrodes are designed and intended to be used with marketed. Electrical Stimulators i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) of PGF (Pulsed Galvanic Stimulation). These electrodes will include the precaution statement: Federal Law restricts the device to sale by or on the order of a licensed practitioner or therapist.

SOF-PACH™ Reusable Neurostimulation Electrodes are non-sterile laminated, flexible structures composed of materials commonly used in this application: First layer - Various cloths, tapes, etc. including Tricot/polyester fabric, polyethylene foam or a polypropylene substrate, coated with biocompatible adhesive. Second layer Electrically conductive carbon coated with or without Ag/AgCl, and Activated Carbon Mesh material. Third layer Biocompatible conductive hydrogel coupling media (CATHAY's Gel) which has passed the required skin sensitivity testing criteria as specified in the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 requirements for skin contact. These tests include Cytotoxicity, Sensitization and Primary Skin Irritation Tests. The electrodes are designed for single-patient/multiple application use. They have a low profile construction designed for comfort under clothing and utilize tan-tone fabric for reduced visibility. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The electrodes have two different types of contact points that can be used to link the stimulation device to the electrodes. These contact points are compatible with standard marketed Neurostimulation devices. 1. Lead wire assembly 6" wire with .080 inch diameter recessed female socket connected to one side of the wire. The lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR Part 898 2. Male snap assembly Two-part sensor and stud mated together.