# K252386: Hot and Cold Compression System  (A02-C-032)

- Pathway: 510(k) (Traditional)
- Applicant: Chengdu Cryo-Push Medical Technology Co.,Ltd
- Decided: Apr 3, 2026 after 246 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). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171685: Med4 Elite, Cool Systems, Inc. (Dba Game Ready) (2017) Summary page 6.

## Indications for use
The device combines cold, heat and compression therapies. It is indicated to treat post-surgical and acute injuries to reduce edema, swelling and pain for which cold and compression are indicated; and it is 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/K252386
Methodology: https://510kreport.com/methodology