21 CFR 882.5860 — Stimulator, Neuromuscular, Implanted
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5860
Identification
An implanted neuromuscular stimulator is a device that provides electrical stimulation to a patient's peroneal or femoral nerve to cause muscles in the leg to contract, thus improving the gait in a patient with a paralyzed leg. The stimulator consists of an implanted receiver with electrodes that are placed around a patient's nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver. The external transmitter is activated by a switch in the heel in the patient's shoe.
Classification Rationale
Class III (premarket approval).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GZC | Stimulator, Neuromuscular, Implanted | 3 | 1 | Implant |
