eCFR Reference Browser

---

title: "21 CFR §890.5850"

source: "https://www.ecfr.gov/current/title-21/section-890.5850"

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: "F"

subpart_subject: "Physical Medicine Therapeutic Devices"

section_number: "890.5850"

section_subject: "Powered muscle stimulator."

cfr_reference: "21 CFR 890.5850"

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 powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

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

§890.5850 - Powered muscle stimulator.