# K083135: Modification to Chillbuster Portable Electric Blanket , Model 8002

- Pathway: 510(k) (Traditional)
- Applicant: Thermogear, Inc.
- Decided: Oct 31, 2008 after 8 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K952329 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071918: Chillbuster Portable Electric Blanket, Model 8002, Thermogear, Inc. (2007) Summary page 1.
- K072513: DM-EMG, Gvp Elettronica Srl (2007) Summary page 1.

## Indications for use
The ChillBuster® Model 8002 has been developed to reduce the effects of hypothermia encountered during the trauma of a surgical procedure or other medical crisis which could result in the onset of a hypothermic condition. Use is limited to whole-body warming in adult humans, free of skin conditions or other impairments where distributed heat application is deemed contraindicated by the responsible physician.

Source page: https://510kreport.com/device/K083135
Methodology: https://510kreport.com/methodology