(203 days)
Electrodes intend for use as re-usable (by single patient), cutaneous, flexible conductive garment / fabric electrodes for interface between electrical stimulators, such as powered muscle stimulators, interferential devices, galvanic devices, trans-cutaneous electrical nerve stimulators etc., and a patient's skin for the delivery of clectrical stimulation.
Thermoskin Conductive Pads are re-usable (by single patient), cutaneous, flexible conductive garment / fabric electrodes.
I am sorry, but the provided text does not contain the information requested. The document is a 510(k) clearance letter from the FDA for a device called "Thermoskin Conductive Pads." It states that the device is substantially equivalent to legally marketed predicate devices and lists its indications for use.
However, the letter does not include any details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. This type of information is typically found in the 510(k) submission itself or in a separate study report, none of which are present in the provided text.
§ 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).