Cleared Traditional

K961855 - POLAR CARE (MODEL 500/50000)

K961855 is an FDA 510(k) clearance for POLAR CARE (MODEL 500/50000), manufactured by Breg, Inc.. The device is a Class 2 Physical Medicine device with product code ILO cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K961855 · Breg, Inc. · Physical Medicine device
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Aug 1996
Decision
87d
Days
Class 2
Risk

K961855 is an FDA 510(k) clearance for the POLAR CARE (MODEL 500/50000). Classified as Pack, Hot Or Cold, Water Circulating (product code ILO), Class II - Special Controls.

Submitted by Breg, Inc. (Vista, US). The FDA issued a Cleared decision on August 9, 1996 after a review of 87 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Breg, Inc. devices

FDA 510(k) Submission Details - K961855

510(k) Number K961855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1996
Decision Date August 09, 1996
Days to Decision 87 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
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 K961855.
THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM
K961621 · Therapy Concepts, Inc. · Oct 1996
BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS
K961425 · Bio Compression Systems, Inc. · Oct 1996
EBI THERMAL THERAPY SYSTEM
K963261 · Electro-Biology, Inc. · Sep 1996
CRYTRON SYSTEM
K955529 · Mark H. Friedman · Jun 1996
SPORTS CONTRAST THERAPY SYSTEM ST 7000
K955326 · Burke Neutech, Inc. · Apr 1996
MODEL 1100 COLD THERAPY DEVICE
K955057 · Smith and Nephew Donjoy, Inc. · Mar 1996