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Cutaneous (Disc) Electrode is intended for non-invasive use as a recording (active/reference) electrode during electromyographic (EMG) recordings.

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This document is a 510(k) premarket notification decision letter from the FDA to Neuro Supplies, Inc. for several types of cutaneous electrodes. It states that the devices are substantially equivalent to legally marketed predicate devices.

Crucially, this document is an FDA clearance letter, not a study report or clinical trial documentation. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications.

The letter is a regulatory approval notice, indicating that the devices (Cutaneous (Bar) Electrode, Cutaneous Ground Electrode, Digital Ring Electrode, and Cutaneous (Disc) Electrode) can be marketed. It confirms that the FDA has determined these devices are substantially equivalent to previously approved devices based on the information provided in the 510(k) submission.

Therefore, I cannot provide the requested information because it is not present in the provided text. The prompt asks for details that would typically be found in a clinical study report or a detailed technical submission, neither of which is this document.

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