# K960624: Certi Cool Instant Cold Compress

- Pathway: 510(k) (Traditional)
- Applicant: Certified Safety Mfg., Inc.
- Decided: May 6, 1996 after 83 days
- Product code: IMD (Pack, Hot Or Cold, Disposable)
- Device class: 1
- Regulation: 21 CFR 890.5710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K871006 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871006: Edcool and Edcool JR. Instant Cold Pack, Advantage Credit Services, Inc. (1987) Summary page 1.

## Indications for use
The Certi*Cool Instant Cold Compress is a self contained disposable unit that provides temporary cold therapy for body surfaces.

Source page: https://510kreport.com/device/K960624
Methodology: https://510kreport.com/methodology