← Product Code [KZM](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/KZM) · K810528

# MODEL EM-IR (K810528)

_Myo-Tronics Research, Inc. · KZM · Mar 31, 1981 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/KZM/K810528

## Device Facts

- **Applicant:** Myo-Tronics Research, Inc.
- **Product Code:** [KZM](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/KZM.md)
- **Decision Date:** Mar 31, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.1375
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory Identification

A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/KZM/K810528](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/KZM/K810528)

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