Cleared Special

K070402 - MODIFICATION TO POLAR CARE 500 (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K070402 · Breg, Inc. · Physical Medicine device
Mar 2007
Decision
45d
Days
Class 2
Risk

K070402 is an FDA 510(k) clearance for the MODIFICATION TO POLAR CARE 500. 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 March 29, 2007 after a review of 45 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K070402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2007
Decision Date March 29, 2007
Days to Decision 45 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Statement
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 151d · This submission: 45d
Pathway characteristics
Modification to existing cleared device.

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.