# K193079: ICE COMPRESSION FIRST, DUO, & MOOVE Systems

- Pathway: 510(k) (Traditional)
- Applicant: Mks Paris
- Decided: Jan 11, 2021 after 433 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: 4 generations back to K944567 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192114: Game Ready GRPro 2.1 System, Cool Systems, Inc. (Dba Game Ready) (2019) Summary page 5.
- K171685: Med4 Elite, Cool Systems, Inc. (Dba Game Ready) (2017) Summary page 5.

## Indications for use
The ICE COMPRESSION FIRST, DUO, and MOOVE Systems combine cold and compression therapies. They are intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. They are intended to be used by or on the order of licensed healthcare professionals in hospital, outpatient clinics, athletic training settings, or home settings.

Source page: https://510kreport.com/device/K193079
Methodology: https://510kreport.com/methodology