Cleared Traditional

TENS-IT, FITTRONIC II, (MORE LATER) (K946018) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K946018 · Ems, Inc. · Neurology device
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Nov 1995
Decision
335d
Days
Class 2
Risk

K946018 is an FDA 510(k) clearance for the TENS-IT, FITTRONIC II, (MORE LATER). Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Ems, Inc. (Pen Valley, US). The FDA issued a Cleared decision on November 9, 1995 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1330 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ems, Inc. devices

Submission Details

510(k) Number K946018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1994
Decision Date November 09, 1995
Days to Decision 335 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 148d · This submission: 335d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZL Electrode, Depth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GZL Electrode, Depth

All 57
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K946018.
Wovyn Depth Electrode
K253970 · Sensomedical Labs, Ltd. · Apr 2026
Depth Electrode (RSDE-08)
K250363 · Beijing Sinovation Medical Technology Co., Ltd. · Nov 2025
Neuro Omega System
K250601 · Alpha Omega Engineering , Ltd. · Mar 2025
Spencer Probe Depth Electrodes
K223269 · Ad-Tech Medical Instrument Corporation · May 2023
Anchor Bolts as Accessories to Depth Electrodes
K223276 · Ad-Tech Medical Instrument Corporation · May 2023
SENSOSEEG Depth Electrodes
K213170 · Sensomedical Labs, Ltd. · Apr 2023