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The Columbia Scientific, Inc. cutaneous electrotherapy and recording electrodes are intended to be used to apply electrical stimulation current to the patient's skin or record physiological signals. Example electrical stimulation current applications of these electrodes are: - a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief. - b) Electrical muscle stimulation (EMS) for neck muscle stimulation - c) Functional electrical stimulation (FES). - d) Galvanic stimulation. - e) Microcurrent electrical nerve stimulation (MENS). - f) Interferential stimulation. - g) Neuromuscular electrical stimulation (NMES).

Single patient use cutaneous electrodes for the application of electrical stimulation are intended to be used to apply electrical stimulation current to the patient's skin or record physiological signals. The Leadwire is attached to the electrode and is designed to be connected to a transcutaneous external muscle stimulator. The cutaneous electrodes are single patient /multiple application use and are composed of materials commonly used in this application: First Layer- Tricot/polyester fabric, coated with biocompatible adhesive. Second layer- Electrically conductive Activated Carbon Mesh material. Third layer- Biocompatible conductive Hydrogel coupling media that has been tested for biocompatibility. Test report T1262-809 NAMSA CA. Division The electrode has one type of connection point that can be used to connect to the stimulation device (For e.g. VitalStim NMES model 5900 or 5905). The lead wire assembly is 60" with .080 inch diameter recessed female socket that is in compliance with IEC 601-1(plus amendments) and section 56.3 of 21 CFR 898.12 Performance Standard and connects to the electrode and the electrical stimulation devices.