# K963768: Instant Hot Packs

- Pathway: 510(k) (Traditional)
- Applicant: Kick Ice, Inc.
- Decided: Nov 25, 1996 after 67 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
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. The FDA summary names its predicate without a number.
- (no number) Jack Frost Laboratories Instant Hot Pack: named in the summary without a submission number

## Indications for use
The device provides instant hot treatment used for first aid purposes to reduce local pain and discomfort.

Source page: https://510kreport.com/device/K963768
Methodology: https://510kreport.com/methodology