Cleared Traditional

K940858 - THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS)

K940858 is an FDA 510(k) clearance for THERA COOL HOME UNIT/COOLPAC(AMBU/RESER..., manufactured by Innovation Sports, Inc.. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K940858 · Innovation Sports, Inc. · Physical Medicine device
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Jul 1994
Decision
139d
Days
Class 2
Risk

K940858 is an FDA 510(k) clearance for the THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS). Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Innovation Sports, Inc. (Irvine, US). The FDA issued a Cleared decision on July 12, 1994 after a review of 139 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 Innovation Sports, Inc. devices

FDA 510(k) Submission Details - K940858

510(k) Number K940858 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 23, 1994
Decision Date July 12, 1994
Days to Decision 139 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
24d slower than avg
Panel avg: 115d · This submission: 139d
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 K940858.
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HOT/ICE SYSTEM STERILE CONFORMABLE/DISP. BLANKETS
K931843 · Hollister, Inc. · Feb 1994
SUR FLO THERMAL THERAPY PADS
K930634 · Buckman Co., Inc. · Nov 1993
MEDICOOL
K923643 · Micromedic Systems · Mar 1993