# K253919: Cryo And Thermo Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Xiamen Weiyou Intelligent Technology Co., Ltd.
- Decided: Jun 10, 2026 after 184 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: 5 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)
- K242754: ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A), Zamar Medical D.O.O. (2025) Summary page 5.

## Indications for use
Cryo And Thermo Therapy System ( Model:VU-COTO02) : The device provides a combination of cold, heat, contrast, and compression therapies. It is intended to treat post-surgical and trauma 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. The equipment is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, athletic training settings and home settings. Cryo And Thermo Therapy System (Model: VU-COT01-V1, VU-COT01-V2, VU-COTO03) : The device provides a combination of cold, heat, contrast, and compression therapies. It is intended to treat post-surgical and trauma 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. The equipment is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, and athletic training settings.

Source page: https://510kreport.com/device/K253919
Methodology: https://510kreport.com/methodology