Search Results

The Pepin Manufacturing, 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); Powered Muscle Stimulators. c) Functional electrical stimulation (FES). d) Galvanic stimulation. e) Microcurrent electrical nerve stimulation (MENS). f) Interferential stimulation. g) Neuromuscular electrical stimulation (NMES).

Pepin Manufacturing Incorporated (PMI) has a 510(k) clearance for TENS Electrodes, reference 510(k) K932849. This 510(k) submission addresses two modifications to these electrodes: 1) Sterile TENS electrodes variation will be commercially available. 2) Use of these TENS electrodes as cutaneous electrotherapy electrodes consistent with the cutaneous electrode classification, 21 CFR 882.1320: "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." The electrodes described by this 510(k) submission remain single patient use devices. The electrodes provide the patient contact device when connected to commercially available electrotherapy (electrical stimulation) and recording devices. The cutaneous electrotherapy and recording electrodes do not contain active electronics, software or firmware. The cutaneous electrotherapy electrodes connect to the user's electronic device. The electrode construction is equivalent to the predicate devices.

The Pepin Manufacturing, Inc. iontophoresis electrodes are intended to be used to introduce soluble salts and other dugs into the body.

Iontophoresis electrodes described in this application are single patient use, disposable, nonsterile devices. Fundamentally the iontophoresis electrodes consist of two skin contacting electrodes: a drug delivery electrode and a return electrode. When connected to the user's iontophoresis electronic device, the electrodes localize administration of ionic drug solutions into the body for medical purposes. The electrodes provide the patient contact device. The electrodes are used under the supervision of a physician or other medical professional. The iontophoresis electrodes are intended for use only with approved drugs delivered by iontophoresis technology. There are variations of sizes and shapes of the drug delivery electrode. The size of the return electrode is constant for all drug delivery electrode variations. The iontophoresis electrodes do not include lead wires. The electrode electrical contact is made by a snap on the electrode. lontophoresis electrodes are used under the direct supervision of a physician or medical professional. The electrodes are placed in contact with the skin to support introduction of soluble salts and other dugs into the body. The iontophoresis electrodes do not contain active electronics, software or firmware. The electrodes connect to the user's iontophoresis electronic device. The drug delivery electrode is a buffed gel covered carbon electrode. The return electrode is a buffered hydrogel material electrode. Electrode material biocompatibility is addressed in the submission.