← Product Code [GZI](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZI) · K010837

# HANDMASTER (K010837)

_Neuromusclar Electrical Stimulation Systems, Ltd. · GZI · Jun 15, 2001 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZI/K010837

## Device Facts

- **Applicant:** Neuromusclar Electrical Stimulation Systems, Ltd.
- **Product Code:** [GZI](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZI.md)
- **Decision Date:** Jun 15, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.5810
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZI/K010837](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZI/K010837)

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