# K181149: Therm-X Pro, Therm-X AT, Therm-X Pro Athlete

- Pathway: 510(k) (Traditional)
- Applicant: Zenith Technical Innovations
- Decided: Aug 3, 2018 after 94 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 K881632 (1988). 23 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 36 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.
- K061866: Nanotherm,  Vascutherm and Prothermo Therapy Wraps, Thermotek, Inc. (2006) Summary page 5.
- K072620: Game Ready Classic System, Model 550550, Coolsystems, Inc. (2007) Summary page 5.
- K131327: Bioarterial Plus Arterial Blood Flow Enhancement System, Bio Compression Systems, Inc. (2013) Summary page 5.

## Most influential descendants
- K190854: Therm-X (2019), 11 descendants of its own
- K193550: Therm-X (2020), 10 descendants of its own
- K223729: FLOWpresso (2023), 3 descendants of its own
- K232965: Leg Massager (Models:RP-ALM070H, RP-ALM071H) (2024), 2 descendants of its own
- K223541: Cold/Hot Compression (2023), 2 descendants of its own

## Indications for use
Therm-X (Therm-X Pro, Therm-X Pro Athlete, and Therm-X AT) combines cold, heat, contrast, and compression therapy. Therm-X 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. Therm-X Pro and Therm-X Pro Athlete systems also provide DVT therapy. Therm-X Pro and Therm-X Pro Athlete are intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression. Therm-X (Therm-X Pro, Therm-X Pro Athlete and Therm-X AT) 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.

Source page: https://510kreport.com/device/K181149
Methodology: https://510kreport.com/methodology