# K070402: Modification to Polar Care 500

- Pathway: 510(k) (Special)
- Applicant: Breg, Inc.
- Decided: Mar 29, 2007 after 45 days
- Product code: ILO (Pack, Hot Or Cold, Water Circulating)
- Device class: 2
- Regulation: 21 CFR 890.5720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Local anesthetic effect which significantly reduces pain following an injury, surgery or rehabilitative therapy Early use of cold therapy following an injury or surgery will reduce primary bleeding and swelling Temporary decrease in blood circulation, where applied, reduces pain and swelling.

Source page: https://510kreport.com/device/K070402
Methodology: https://510kreport.com/methodology