GZC · Stimulator, Neuromuscular, Implanted
Neurology · 21 CFR 882.5860 · Class 3
Overview
| Product Code | GZC |
|---|---|
| Device Name | Stimulator, Neuromuscular, Implanted |
| Regulation | 21 CFR 882.5860 |
| Device Class | Class 3 |
| Review Panel | Neurology |
| Implant | Yes |
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).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P950035 | NEUROCONTROL FREEHAND SYSTEM(R) | Biocontrol Technology, Inc. | Aug 15, 1997 | APPR |
Top Applicants
- Biocontrol Technology, Inc. — 1 clearance
