# K964006: Incare Hot/Ice System Blankets (Various Sizes and Shapes)

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Dec 31, 1996 after 85 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
Longest line of descent: 1 generation back to K833564 (1983). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871962: Hot/Ice Dual Function Equipment, Thermo Temp, Inc. (1987) Summary page 1.
- K871963: Hot/Ice Disposable Blanket, Thermo Temp, Inc. (1987) Summary page 1.
- K833564: Hot/Ice Disposable Blanket, Thermo Temp, Inc. (1983) Summary page 1.
- (no number) ImmobillCE Support Blankets: named in the summary without a submission number

## Indications for use
The InCare HOT/ICE Cold Therapy Blankets are intended to provide hot/cold therapy for body surfaces.

Source page: https://510kreport.com/device/K964006
Methodology: https://510kreport.com/methodology