← Product Code [IKN](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKN) · K000220

# MA-300 ELECTROMYOGRAPHY SYSTEM (K000220)

_Motion Lab Systems, Inc. · IKN · Feb 24, 2000 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKN/K000220

## Device Facts

- **Applicant:** Motion Lab Systems, Inc.
- **Product Code:** [IKN](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKN.md)
- **Decision Date:** Feb 24, 2000
- **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/NE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKN/K000220](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKN/K000220)

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