Cleared Traditional

K833086 - NEUROTRON 100

K833086 is the FDA 510(k) clearance for NEUROTRON 100 by Neutro-Tronics. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K833086 · Neutro-Tronics · Neurology device
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Jan 1984
Decision
113d
Days
Class 2
Risk

K833086 is an FDA 510(k) clearance for the NEUROTRON 100. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Neutro-Tronics (Walker, US). The FDA issued a Cleared decision on January 24, 1984 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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. Standard predicate reliance. 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 Neutro-Tronics devices

Submission Details

510(k) Number K833086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1983
Decision Date January 24, 1984
Days to Decision 113 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 148d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 140
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K833086.
SD PLUS PATIENT CAT.#78-8010
K840963 · Codman & Shurtleff, Inc. · Apr 1984
SD PLUS CLINICIAN CAT# 78-8015
K840964 · Codman & Shurtleff, Inc. · Apr 1984
EMPI MODEL 984 BASIX, TENS
K841045 · Empi · Apr 1984
NEUROMOD COMFORT WAVE #7721 DUAL-
K832238 · Medtronic Vascular · Aug 1983
SPEC IISX
K831413 · Medical Devices, Inc. · Jun 1983
NEUROMOD COMPLEMENT #7724 DUAL CHANNEL
K823742 · Medtronic Vascular · Jan 1983