Cleared Special

MODIFICATION TO POLAR CARE 500

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

About This 510(k) Submission

K070402 is an FDA 510(k) clearance for the MODIFICATION TO POLAR CARE 500, a Pack, Hot Or Cold, Water Circulating (Class II — Special Controls, product code ILO), submitted by Breg, Inc. (Vista, US). The FDA issued a Cleared decision on March 29, 2007, 45 days after receiving the submission on February 12, 2007. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5720.

Submission Details

510(k) Number K070402 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code ILO — Pack, Hot Or Cold, Water Circulating
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5720