(182 days)
Intended to be applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
Home Care various models of self-adhesive electrodes - FA, CA, TA, FI, TI, FR, CR, and R Series
The provided document is a 510(k) premarket notification letter from the FDA regarding self-adhesive electrodes. This type of document is a regulatory approval letter and does not contain information about acceptance criteria, study designs, or performance metrics in the way you've requested for a device evaluation.
Therefore, I cannot provide the requested information. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not detail the technical performance criteria or the studies that would typically be described in a clinical or validation report for a novel medical AI device.
§ 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).