# K961621: Therapy Concepts Water Circulating Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Therapy Concepts, Inc.
- Decided: Oct 31, 1996 after 188 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) HOT/ICE Cold Therapy Cooler System: named in the summary without a submission number

## Indications for use
The Therapy Concepts Water Circulating Treatment System will be used to pump chilled or room temperature water through a plastic pad that is placed on a mattress underneath the user and in so doing, will provide cold temperature therapy intended to temporarily assist in the localized reduction of minor swelling and pain. Pre-chilled water will be provided by adding ice cubes and water to the reservoir. The cooling rate is adjusted by adjusting the rate of flow of the water through the plastic pad.

Source page: https://510kreport.com/device/K961621
Methodology: https://510kreport.com/methodology