(78 days)
Electrodes intended for use as reusable (by a single patient), cutaneous, flexible, conductive garment/fabric electrodes for interface between electrical stimulators such as powered muscle stimulators, interferential devices, qalvanic devices, transcutaneous electrical nerve stimulators, etc. and a patient's skin for the delivery of electrical stimulation.
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This is a premarket notification for AG Garments Conductive Electrodes (K023212). The provided document is a 510(k) clearance letter from the FDA, indicating substantial equivalence to a predicate device. It does not contain information about acceptance criteria or specific study results that prove the device meets such criteria.
The document primarily focuses on regulatory approval based on substantial equivalence to an existing device, rather than detailed performance study outcomes typically found in a clinical study report or a summary of safety and effectiveness data.
Therefore, I cannot provide the requested information from this document. To answer your questions, one would need access to the actual 510(k) submission, specifically the sections dealing with performance testing and clinical data, if any were submitted beyond basic electrical and biocompatibility testing for an electrode.
§ 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).