# K073675: T-Pump Localized Temperature Therapy Pump

- Pathway: 510(k) (Traditional)
- Applicant: Gaymar Industries, Inc.
- Decided: May 8, 2008 after 132 days
- Product code: ILO (Pack, Hot Or Cold, Water Circulating)
- Device class: 2
- Regulation: 21 CFR 890.5720
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K760804 (1976). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K760804: T-Pump, Temperature - Therapy Pump, Gaymar Industries, Inc. (1976) Summary page 1.
- K970197: HTP-1500 Localized Heat Therapy Pump, Adroit Medical Systems, Inc. (1997) Summary page 1.

## Recalls of this device
- Nov 7, 2017 · Class III · Z-1013-2018: The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence, Temperature therapy can also be for heat conservation for normothermia maintenance to the Indications 

## Indications for use
The T-Pump Localized Temperature Therapy Pump is intended for use in supplying warm or cold water at controlled temperatures via water circulating pad for the application of localized therapy in situations where a physician determines that temperature therapy is necessary or desirable. Localized temperature therapy is of particular benefit in treating the following: orthopedic conditions such as acute injuries, chronic pain, lower back pain, muscle spasm and strains; skin trauma such as abscesses, boils, bruises, bums and contusions; other medical conditions such as chronic arthritis, neuritis, phlebitis, tendonitis and I.V. infiltration; and symptoms such as infection and localized pain.

Source page: https://510kreport.com/device/K073675
Methodology: https://510kreport.com/methodology