21 CFR § 882.5810 - External functional neuromuscular stimulator.

---
identifier: "/us/cfr/t21/s882.5810"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 882.5810 - External functional neuromuscular stimulator."
title_number: 21
title_name: "Food and Drugs"
section_number: "882.5810"
section_name: "External functional neuromuscular stimulator."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "882"
part_name: "NEUROLOGICAL 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: "44 FR 51730, Sept. 4, 1979, unless otherwise noted."
cfr_part: "882"
---


# 882.5810 External functional neuromuscular stimulator.

(a) *Identification.* An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.

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