Cleared Traditional

THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS) (K940858) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 92
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