§ 890.1385. Diagnostic electromyograph needle electrode.
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/us/cfr/t21/s§ 890.1385·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).
(b)Classification. Class II (performance standards).