(203 days)
The Cutaneous Electrodes including Garment electrodes, which are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The cutaneous electrodes will deliver the stimulation signals generated by the body surface with which they are in contact. The Garment electrodes including glove, socks, sleeve, knee belt and back belt which are made up of silver or conductive silicone rubber.
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This is a 510(k) premarket notification for "Cutaneous Electrodes." This document does not describe a study that uses AI or machine learning models. Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device.
The document discusses the regulatory approval for medical electrodes and their intended use, but it does not involve any performance evaluation of an intelligent algorithm.
§ 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).