# K242754: ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)

- Pathway: 510(k) (Traditional)
- Applicant: Zamar Medical D.O.O.
- Decided: May 5, 2025 after 235 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.
1 later device descends from it; 1 cites it directly.
0 of 15 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 5.

## Most influential descendants
- K253919: Cryo And Thermo Therapy System (2026), 0 descendants of its own

## Indications for use
The Heat Exchange Equipment for Cryotherapy and Thermotherapy 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/K242754
Methodology: https://510kreport.com/methodology