← Product Code [IKT](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKT) · K961013

# DISPOSABLE NEEDLE ELECTRODE (K961013)

_Medelec Intl. Corp. · IKT · Dec 20, 1996 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKT/K961013

## Device Facts

- **Applicant:** Medelec Intl. Corp.
- **Product Code:** [IKT](/submissions/PM/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKT.md)
- **Decision Date:** Dec 20, 1996
- **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/K961013](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94physical-medicine-diagnostic-devices/IKT/K961013)

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