Cleared Traditional

K900356 - THERMOAIRE SPLINT (TM) (TAS)

K900356 is an FDA 510(k) clearance for THERMOAIRE SPLINT (TM) (TAS), manufactured by Life Enhancement Technologies, LLC. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K900356 · Life Enhancement Technologies, LLC · Physical Medicine device
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May 1990
Decision
102d
Days
Class 2
Risk

K900356 is an FDA 510(k) clearance for the THERMOAIRE SPLINT (TM) (TAS). Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Life Enhancement Technologies, LLC (Bethesda, US). The FDA issued a Cleared decision on May 7, 1990 after a review of 102 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 Life Enhancement Technologies, LLC devices

FDA 510(k) Submission Details - K900356

510(k) Number K900356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1990
Decision Date May 07, 1990
Days to Decision 102 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
13d faster than avg
Panel avg: 115d · This submission: 102d
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 K900356.
INCARE HOT/ICE SYSTEM 3
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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