eCFR Reference Browser

---

title: "21 CFR §890.1850"

source: "https://www.ecfr.gov/current/title-21/section-890.1850"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "890"

part_subject: "PHYSICAL MEDICINE DEVICES"

subpart_code: "B"

subpart_subject: "Physical Medicine Diagnostic Devices"

section_number: "890.1850"

section_subject: "Diagnostic muscle stimulator."

cfr_reference: "21 CFR 890.1850"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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).

§890.1850 - Diagnostic muscle stimulator.