← Product Code [GZC](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZC) · P950035

# NEUROCONTROL FREEHAND SYSTEM(R) (P950035)

_Biocontrol Technology, Inc. · GZC · Aug 15, 1997 · Neurology · APPR_

**Canonical URL:** https://fda.innolitics.com/submissions/PHYSICAL%20MEDICINE/subpart-f%E2%80%94neurological-therapeutic-devices/GZC/P950035

## Device Facts

- **Applicant:** Biocontrol Technology, Inc.
- **Product Code:** [GZC](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZC.md)
- **Decision Date:** Aug 15, 1997
- **Decision:** APPR
- **Regulation:** 21 CFR 882.5860
- **Device Class:** Class 3
- **Review Panel:** Neurology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/PHYSICAL%20MEDICINE/subpart-f%E2%80%94neurological-therapeutic-devices/GZC/P950035](https://fda.innolitics.com/submissions/PHYSICAL%20MEDICINE/subpart-f%E2%80%94neurological-therapeutic-devices/GZC/P950035)

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