← Product Code [GZL](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL) · K946018

# TENS-IT, FITTRONIC II, (MORE LATER) (K946018)

_Ems, Inc. · GZL · Nov 9, 1995 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K946018

## Device Facts

- **Applicant:** Ems, Inc.
- **Product Code:** [GZL](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL.md)
- **Decision Date:** Nov 9, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.1330
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K946018](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZL/K946018)

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