Cleared Traditional

K955326 - SPORTS CONTRAST THERAPY SYSTEM ST 7000

K955326 is an FDA 510(k) clearance for SPORTS CONTRAST THERAPY SYSTEM ST 7000, manufactured by Burke Neutech, Inc.. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K955326 · Burke Neutech, Inc. · Physical Medicine device
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Apr 1996
Decision
142d
Days
Class 2
Risk

K955326 is an FDA 510(k) clearance for the SPORTS CONTRAST THERAPY SYSTEM ST 7000. Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Burke Neutech, Inc. (St. Petersburg, US). The FDA issued a Cleared decision on April 10, 1996 after a review of 142 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 Burke Neutech, Inc. devices

FDA 510(k) Submission Details - K955326

510(k) Number K955326 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 20, 1995
Decision Date April 10, 1996
Days to Decision 142 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
27d slower than avg
Panel avg: 115d · This submission: 142d
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 41
Devices cleared under the same product code (ILO) and FDA review panel - the closest regulatory comparables to K955326.
EBI THERMAL THERAPY SYSTEM
K963261 · Electro-Biology, Inc. · Sep 1996
POLAR CARE (MODEL 500/50000)
K961855 · Breg, Inc. · Aug 1996
CRYTRON SYSTEM
K955529 · Mark H. Friedman · Jun 1996
MODEL 1100 COLD THERAPY DEVICE
K955057 · Smith and Nephew Donjoy, Inc. · Mar 1996
MEDICOOL (MODIFICATON)
K954095 · Microclimate Systems, Inc. · Mar 1996
EBICE
K953532 · Electro-Biology, Inc. · Oct 1995