← Product Code [IKT](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKT) · K912282

# DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS (K912282)

_Chalgren Enterprises, Inc. · IKT · Mar 16, 1992 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKT/K912282

## Device Facts

- **Applicant:** Chalgren Enterprises, Inc.
- **Product Code:** [IKT](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKT.md)
- **Decision Date:** Mar 16, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.1385
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory Identification

A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKT/K912282](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKT/K912282)

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