# K171685: Med4 Elite

- Pathway: 510(k) (Traditional)
- Applicant: Cool Systems, Inc. (Dba Game Ready)
- Decided: Sep 29, 2017 after 114 days
- Product code: IRP (Massager, Powered Inflatable Tube)
- Device class: 2
- Regulation: 21 CFR 890.5650
- 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 K944567 (1995). 12 ancestors in all.
21 later devices descend from it; 8 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072620: Game Ready Classic System, Model 550550, Coolsystems, Inc. (2007) Summary page 4.
- K061866: Nanotherm,  Vascutherm and Prothermo Therapy Wraps, Thermotek, Inc. (2006) Summary page 4.

## Most influential descendants
- K181149: Therm-X Pro, Therm-X AT, Therm-X Pro Athlete (2018), 12 descendants of its own
- K190854: Therm-X (2019), 11 descendants of its own
- K193550: Therm-X (2020), 10 descendants of its own
- K223729: FLOWpresso (2023), 3 descendants of its own
- K183702: Polar Care Wave (2019), 3 descendants of its own

## Indications for use
The Med4 Elite™ combines cold, heat, contrast and compression therapies. It is intended to treat post-surgical and acute injuries to reduce edema, swelling and pain for which cold and compression are indicated. It is intended to treat post traumatic and post surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold or contrast) are indicated. It is intended to be used by, or on the order of, licensed healthcare professionals in rehabilitation facilities, outpatient clinics, and athletic training settings.

Source page: https://510kreport.com/device/K171685
Methodology: https://510kreport.com/methodology