(64 days)
Adhesive Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. It is intended to be used with U.S. legally marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).
Adhesive Electrodes
This document is a 510(k) premarket notification letter from the FDA regarding "Reno Medical Adhesive Electrodes". It focuses on the regulatory approval of the device based on substantial equivalence to existing predicate devices.
Based on the provided text, there is no information about acceptance criteria, a study proving the device meets acceptance criteria, or any of the detailed study parameters you've requested.
The letter explicitly states:
- "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This indicates that the approval is based on a comparison to existing devices, not a new study demonstrating performance against specific acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria or details about a study to prove device performance because this information is not present in the provided FDA letter.
The document is a regulatory approval letter, not a scientific study report.
§ 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).