Cleared Traditional

K891603 - BODY COOLER OR COOLVEST OR ALPHA BODY COOLER

K891603 is an FDA 510(k) clearance for BODY COOLER OR COOLVEST OR ALPHA BODY C..., manufactured by Alpha Rehabilitation Products. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K891603 · Alpha Rehabilitation Products · Physical Medicine device
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Jul 1989
Decision
127d
Days
Class 2
Risk

K891603 is an FDA 510(k) clearance for the BODY COOLER OR COOLVEST OR ALPHA BODY COOLER. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Alpha Rehabilitation Products (Westminster, US). The FDA issued a Cleared decision on July 25, 1989 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5720 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Alpha Rehabilitation Products devices

FDA 510(k) Submission Details - K891603

510(k) Number K891603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1989
Decision Date July 25, 1989
Days to Decision 127 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 115d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILO Device Classification - Class 2, Special Controls

Product Code ILO Pack, Hot Or Cold, Water Circulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5720
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 - ILO Pack, Hot Or Cold, Water Circulating

All 44
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K891603.
INCARE HOT/ICE SYSTEM 3
K915196 · Hollister, Inc. · Feb 1992
HYPER-K HEAT SYSTEM
K912722 · Baxter Healthcare Corp · Sep 1991
K-MODULE II HEAT THERAPY SYSTEM
K910061 · Baxter Healthcare Corp · Feb 1991
COOL 'N HEAT MACHINE
K891151 · Kinetic Concepts, Inc. · Apr 1989
GRAND COOLING MACHINE
K891152 · Kinetic Concepts, Inc. · Mar 1989
CONCEPT CCT-5200, THERMAL THERAPY SYSTEM
K884255 · Concept, Inc. · Nov 1988