# K222136: Cryo-Thermo Compression Device (FGK002)

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Microport Rehabtech (Group) Co., Ltd.
- Decided: Mar 8, 2023 after 232 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: 7 generations back to K881632 (1988). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193550: Therm-X, Zenith Technical Innovations (2020) Summary page 4.
- K171685: Med4 Elite, Cool Systems, Inc. (Dba Game Ready) (2017) Summary page 4.

## Indications for use
Cryo-Thermo Compression Device combines cold, heat 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) 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/K222136
Methodology: https://510kreport.com/methodology