CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 890—PHYSICAL MEDICINE DEVICES > SUBPART B—Physical Medicine Diagnostic Devices (§890.1175 to §890.1925) > 890.1385—Diagnostic electromyograph needle electrode.

890.1385—Diagnostic electromyograph needle electrode.

(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).