(63 days)
Top-Rank Adhesive Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed, Electrical Stimulators i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).
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The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Top-Rank Adhesive Electrode." This document is a regulatory approval letter and does not contain any information about acceptance criteria, study details, performance metrics, ground truth establishment, or sample sizes related to the device's technical performance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input document. The document primarily focuses on the device's classification, intended use, and regulatory compliance for marketing purposes in the US.
§ 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).