21 C.F.R. § 890.1385 Diagnostic electromyograph needle electrode.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 890—PHYSICAL MEDICINE DEVICES
Subpart B—Physical Medicine Diagnostic Devices
§ 890.1385 Diagnostic electromyograph needle electrode.
