21 CFR 890.1385
§ 890.1385 Diagnostic electromyograph needle electrode.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 890.1385, § 890.1385 Diagnostic electromyograph needle electrode, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91162
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.