← Product Code [GZI](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZI) · K800380

# FES ORTHOSIS MODEL NO. 2000 (K800380)

_Empi · GZI · Mar 17, 1980 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZI/K800380

## Device Facts

- **Applicant:** Empi
- **Product Code:** [GZI](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZI.md)
- **Decision Date:** Mar 17, 1980
- **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/K800380](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZI/K800380)

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