← Product Code [GZI](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZI) · K912615

# ROCHE COBAS ARGOS 5 DIFF (K912615)

_Roche Diagnostic Systems, Inc. · GZI · Sep 27, 1991 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94neurological-therapeutic-devices/GZI/K912615

## Device Facts

- **Applicant:** Roche Diagnostic Systems, Inc.
- **Product Code:** [GZI](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZI.md)
- **Decision Date:** Sep 27, 1991
- **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/HE/subpart-f%E2%80%94neurological-therapeutic-devices/GZI/K912615](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94neurological-therapeutic-devices/GZI/K912615)

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