21 CFR § 882.5810 Neurological Devices

§ 882.5810 External functional neuromuscular stimulator.

Current through Sep 8, 2026 · Read all of Part 882

⚠ 2 pending changes to Part 882

(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).

← § 882.5808 Transcranial magnetic stimulator for headache.§ 882.5820 Implanted cerebellar stimulator. →