510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070402Substantially Equivalent

Modification to Polar Care 500

Breg, Inc., Vista CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K070402 is the FDA 510(k) clearance record for MODIFICATION TO POLAR CARE 500, a class II device, cleared for Breg, Inc. on under FDA product code ILO (Pack, Hot Or Cold, Water Circulating). FDA records list 11 510(k) clearances for Breg, Inc., from to . As of , FDA records show no recalls naming K070402.

Clearance record

Decision date
Received
(45 days to decision)
Product code
ILO Pack, Hot Or Cold, Water Circulating
Regulation
21 CFR 890.5720
Device class
Class II
Review panel
Physical Medicine
Applicant
Breg, Inc. 2611 Commerce Way, Vista CA
510(k) summary
Statement
Third party review
No

Clearances, product code ILO

Trailing 12 months

FDA records hold no clearances under product code ILO in the trailing twelve months.

FDA records show no clearances under product code ILO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ILO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260