21 CFR § 890.1375 - Diagnostic electromyograph.

---
identifier: "/us/cfr/t21/s890.1375"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 890.1375 - Diagnostic electromyograph."
title_number: 21
title_name: "Food and Drugs"
section_number: "890.1375"
section_name: "Diagnostic electromyograph."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "890"
part_name: "PHYSICAL MEDICINE DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "48 FR 53047, Nov. 23, 1983, unless otherwise noted."
cfr_part: "890"
---


# 890.1375 Diagnostic electromyograph.

(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).