Cleared Traditional

K823465 - AUTO-TENS MODEL II SINGLE CHANNEL

K823465 is the FDA 510(k) clearance for AUTO-TENS MODEL II SINGLE CHANNEL by Cbc Corp.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K823465 · Cbc Corp. · Neurology device
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Feb 1983
Decision
75d
Days
Class 2
Risk

K823465 is an FDA 510(k) clearance for the AUTO-TENS MODEL II SINGLE CHANNEL. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Cbc Corp. (Mchenry, US). The FDA issued a Cleared decision on February 2, 1983 after a review of 75 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cbc Corp. devices

Submission Details

510(k) Number K823465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1982
Decision Date February 02, 1983
Days to Decision 75 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 148d · This submission: 75d
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 K823465.
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