Cleared Traditional

K823466 - AUTO-TENS MODEL III DUAL CHANNEL REPLACE

K823466 is the FDA 510(k) clearance for AUTO-TENS MODEL III DUAL CHANNEL REPLACE by Cbc Corp.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K823466 · Cbc Corp. · Neurology device
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Mar 1983
Decision
108d
Days
Class 2
Risk

K823466 is an FDA 510(k) clearance for the AUTO-TENS MODEL III DUAL CHANNEL REPLACE. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Cbc Corp. (Walker, US). The FDA issued a Cleared decision on March 7, 1983 after a review of 108 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 Cbc Corp. devices

Submission Details

510(k) Number K823466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1982
Decision Date March 07, 1983
Days to Decision 108 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 148d · This submission: 108d
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 K823466.
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
WRIGHT CARE
K823497 · Dow Corning Wright · Jan 1983
DENDRITE VM-TRANSCUTANEOUS ELEC. NERVE
K823002 · Tri W-G, Inc. · Nov 1982