Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5860](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5860) → GZC — Stimulator, Neuromuscular, Implanted

# GZC · Stimulator, Neuromuscular, Implanted

_Neurology · 21 CFR 882.5860 · Class 3_

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

## Overview

- **Product Code:** GZC
- **Device Name:** Stimulator, Neuromuscular, Implanted
- **Regulation:** [21 CFR 882.5860](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5860)
- **Device Class:** 3
- **Review Panel:** [Neurology](/submissions/NE)
- **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](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZC/P950035.md) | NEUROCONTROL FREEHAND SYSTEM(R) | Biocontrol Technology, Inc. | Aug 15, 1997 | APPR |

## Top Applicants

- Biocontrol Technology, Inc. — 1 clearance

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

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