← Product Code [IKT](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKT) · K896874

# DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12 (K896874)

_Dantec Medical, Inc. · IKT · Jun 18, 1990 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKT/K896874

## Device Facts

- **Applicant:** Dantec Medical, Inc.
- **Product Code:** [IKT](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKT.md)
- **Decision Date:** Jun 18, 1990
- **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/K896874](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKT/K896874)

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