← Product Code [ISB](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/ISB) · K790949

# GALVANIC UNIT (K790949)

_Rami International Corp. · ISB · Aug 16, 1979 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/ISB/K790949

## Device Facts

- **Applicant:** Rami International Corp.
- **Product Code:** [ISB](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/ISB.md)
- **Decision Date:** Aug 16, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.1850
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory Identification

A diagnostic muscle stimulator is a device used mainly with an electromyograph machine to initiate muscle activity. It is intended for medical purposes, such as to diagnose motor nerve or sensory neuromuscular disorders and neuromuscular function.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/ISB/K790949](https://fda.innolitics.com/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/ISB/K790949)

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