(108 days)
PROTENS reusable, self-adhering, over-the-counter Cutaneous electrodes are indicated for use with electrical stimulation device. Some common types of electrical stimulation device include, but are not limited to, transcutaneous nerve stimulation (TENS), electrical muscle stimulation (EMS) device, Neuromuscular Electrical Stimulation (NMES/FES) device and Microcurrent electrical nerve stimulation (MENS), Interferential stimulation (IF). Cutaneous electrodes are passive devices serving as an interface between a user's skin and an electrical stimulation device.
Cutaneous electrodes are passive devices serving as an interface between a user's skin and an electrical stimulation device.
This document is a 510(k) clearance letter from the FDA for Bio Protech Inc.'s PROTENS Reusable Stimulating Electrodes. It states that the device is substantially equivalent to legally marketed predicate devices.
However, the letter does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria.
Therefore, I cannot provide a response to your request as the document does not contain the necessary information.
§ 882.1320 Cutaneous electrode.
(a)
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.(b)
Classification. Class II (performance standards).