21 CFR § 890.1850 - Diagnostic muscle stimulator.

---
identifier: "/us/cfr/t21/s890.1850"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 890.1850 - Diagnostic muscle stimulator."
title_number: 21
title_name: "Food and Drugs"
section_number: "890.1850"
section_name: "Diagnostic muscle stimulator."
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"
---


# 890.1850 Diagnostic muscle stimulator.

(a) *Identification.* A diagnostic muscle stimulator is a device used mainly with an electromyograph machine to initiate muscle activity. It is intended for medical purposes, such as to diagnose motor nerve or sensory neuromuscular disorders and neuromuscular function.

(b) *Classification.* Class II (performance standards).