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The AMPCARE ESP™ system uses the AMPCARE ES™ stimulator in combination with the AMPCARE ES electrodes. The AMPCARE ES powered muscle stimulator is indicated for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction. AMPCARE ES cutaneous electrodes are indicated for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.

The AMPCARE ESP™ system uses the AMPCARE ES™ stimulator in combination with the AMPCARE ES electrodes.

AMPCARE 50709 Series of cutaneous electrodes are intended to be used to apply electrical stimulation current to the patient's skin. 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 (IF) stimulation, and g) Neuromuscular electrical stimulation (NMES), including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.

The new AMPCARE 50709 Series Electrodes device is a family of cutaneous electrodes with various shapes and sizes, which are similar in design and construction to several predicate cutaneous electrodes. AMPCARE electrodes are non-sterile, self-adhering, and are for multiple use by a single patient, available with either pin/socket or snap connections. The new AMPCARE device is designed in accordance with the general design approach of the predicate devices referenced above. Specifically, each electrode in the AMPCARE 50709 Series is constructed with a non-conductive top layer, conductive center layer and adhesive bottom layer. The plastic liner at the bottom of the electrode is peeled away just prior to placement on the patient, consistent with the four predicate devices. The pin/socket connector version of the new device will be provided with a lead wire that is 21 CFR 898 compatible, containing a female recessed socket for electrical connection.