NEUROCONTROL FREEHAND SYSTEM(R)
Device Facts
| Record ID | P950035 |
|---|---|
| Device Name | NEUROCONTROL FREEHAND SYSTEM(R) |
| Applicant | Biocontrol Technology, Inc. |
| Product Code | GZC · Neurology |
| Decision Date | Aug 15, 1997 |
| Decision | APPR |
| Regulation | 21 CFR 882.5860 |
| Device Class | Class 3 |
Regulatory Classification
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.
