Cleared Traditional

K880235 - INTELECT MODEL 120

K880235 is an FDA 510(k) clearance for INTELECT MODEL 120, manufactured by Chattanooga Group, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K880235 · Chattanooga Group, Inc. · Physical Medicine device
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Apr 1988
Decision
79d
Days
Class 2
Risk

K880235 is an FDA 510(k) clearance for the INTELECT MODEL 120. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Chattanooga Group, Inc. (Red Bank, US). The FDA issued a Cleared decision on April 8, 1988 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine 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 - K880235

510(k) Number K880235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1988
Decision Date April 08, 1988
Days to Decision 79 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 157
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K880235.
RICH-MAR CONDUCTIVE GEL II W/ALOE VERA
K890147 · Rich-Mar Corp. · Mar 1989
ENDOMED CV405
K880699 · Henley Intl. · May 1988
RICH-MAR G1000 EMS
K880948 · Rich-Mar Corp. · Apr 1988
GV 11 (TM), MODEL 9700
K881082 · Medical Devices, Inc. · Mar 1988
INTELECT VMS 2, OR INTELECT VMS II
K880234 · Chattanooga Group, Inc. · Feb 1988
RICH-MAR HV-2000 ELECTRICAL MUSCLE STIMULATOR
K874736 · Rich-Mar Corp. · Jan 1988