Cleared Traditional

K974497 - INTELECT

K974497 is an FDA 510(k) clearance for INTELECT, manufactured by Chattanooga Group, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K974497 · Chattanooga Group, Inc. · Neurology device
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Jan 1998
Decision
56d
Days
Class 2
Risk

K974497 is an FDA 510(k) clearance for the INTELECT. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Chattanooga Group, Inc. (Hixson, US). The FDA issued a Cleared decision on January 23, 1998 after a review of 56 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 Chattanooga Group, Inc. devices

FDA 510(k) Submission Details - K974497

510(k) Number K974497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1997
Decision Date January 23, 1998
Days to Decision 56 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 148d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

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 139
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K974497.
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ACU-STIM TENS, AP-101082T
K973980 · Apex Medical Corp. · Jul 1998
NT2000
K972244 · Bio-Medical Research, Ltd. · Feb 1998
BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T
K970429 · Apex Medical Corp. · Apr 1997
EPIX VT
K970203 · Empi · Apr 1997
SMART-TENS, MODEL 456
K961376 · Bio-Medical Research, Ltd. · Sep 1996