21 CFR 890.1375
§ 890.1375 Diagnostic electromyograph.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 890.1375, § 890.1375 Diagnostic electromyograph, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91161
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Full text
(a) Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.
(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.