# K080763: Tablegard Pressure Relieving Patient Warming Mattress, Model: TG 700 HT

- Pathway: 510(k) (Traditional)
- Applicant: Talley Medical
- Decided: May 30, 2008 after 73 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: 3 generations back to K011859 (2002). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011859: Klimamed Thermal Mat & Controller 95 and 55 Watts, Klimamed Technologie Medizingerate GmbH (2002)
- K001149: Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750 Warming Unit, Bair Hugger Blank, Augustine Medical, Inc. (2000)
- K062794: PRN Thermalcare, Model 3000, American Healthcare Products, Inc. (2006) Summary page 1.
- K051419: Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1, Inditherm Medical (2006)

## Indications for use
Use of the Talley TableGard Pressure Relieving Patient Warming Mattress is indicated for use for patients that may be benefited by the application of heat during surgical procedures to help maintain normothermia. It is intended for use in the operating rooms, recovery rooms, intensive care departments, emergency rooms in hospitals and outpatient clinics to assist patients to maintain normal body temperature. The TableGard mattress also includes alternating air support to relieve pressure against soft tissues during prolonged periods of immobilization.

Source page: https://510kreport.com/device/K080763
Methodology: https://510kreport.com/methodology