21 CFR 882.5810 — Stimulator, Neuromuscular, External Functional
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5810
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GZI | Stimulator, Neuromuscular, External Functional | 2 | 61 | 3rd Party |
