Cleared Traditional

K832920 - INTERMITTENT COMPRESSION PUMPS

K832920 is an FDA 510(k) clearance for INTERMITTENT COMPRESSION PUMPS, manufactured by Chattanooga Group, Inc.. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K832920 · Chattanooga Group, Inc. · Physical Medicine device
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Nov 1983
Decision
77d
Days
Class 2
Risk

K832920 is an FDA 510(k) clearance for the INTERMITTENT COMPRESSION PUMPS. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Chattanooga Group, Inc. (Walker, US). The FDA issued a Cleared decision on November 7, 1983 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - 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 - K832920

510(k) Number K832920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1983
Decision Date November 07, 1983
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IRP Device Classification - Class 2, Special Controls

Product Code IRP Massager, Powered Inflatable Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5650
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.