# K252396: Cryo Sport 2.0 (AVA 501)

- Pathway: 510(k) (Traditional)
- Applicant: Avanutri Equipamentos DE Saúde
- Decided: May 29, 2026 after 302 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 Cryo Sport 2.0 combines cold and compression therapies. It is intended to treat post-surgical and acute injuries to reduce edema, swelling and pain for which cold and compression is indicated. It is intended to treat post-traumatic and post-surgical medical and/or surgical conditions for which localized thermal therapy 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/K252396
Methodology: https://510kreport.com/methodology