# K051278: Geratherm Sos-Vacutherm (Thermamed Smartcare)

- Pathway: 510(k) (Traditional)
- Applicant: Rg Ent., Inc.
- Decided: Jun 29, 2006 after 408 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: 1 generation back to K991684 (2000). 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)
- K991684: Chillbuster Portable Electric Blanket System, Model 8001, Thermogear, Inc. (2000) Summary page 1.

## Indications for use
The Geratherm SOS-Vacutherm is a temperature-controlled electric whole body warming system intended for use in preventing or treating the effects of incidental hypothermia in adults while at the rescue scene or during transport by air or ground to a medical facility

Source page: https://510kreport.com/device/K051278
Methodology: https://510kreport.com/methodology