(149 days)
The S Series Electrodes (including S5105, S80120, SG4040, SG4368, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D) are intended for use with transcutaneous neurostimulation devices as over the counter. Some common type of neurostimulation devices include, but are not limited to, TENS devices. Transcutaneous neurostimulation electrodes are passive devices serving as an interface between a patient's skin and a neurostimulation device.
Transcutaneous neurostimulation electrodes are passive devices serving as an interface between a patient's skin and a neurostimulation device.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study design, or other details related to a medical device study. The document is an FDA 510(k) clearance letter for "S Series Electrodes," indicating that the device has been deemed substantially equivalent to a legally marketed predicate device.
The information you are looking for (acceptance criteria, study details, sample sizes, expert qualifications, etc.) would typically be found in a separate study report or regulatory submission, which is not included in this document.
Therefore, I cannot provide a response based on the given input as the requested information is absent.
§ 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).