# K193550: Therm-X

- Pathway: 510(k) (Traditional)
- Applicant: Zenith Technical Innovations
- Decided: Feb 28, 2020 after 70 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: 6 generations back to K881632 (1988). 25 ancestors in all.
10 later devices descend from it; 5 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)
- K190854: Therm-X, Zenith Technical Innovations (2019) Summary page 4.
- K181149: Therm-X Pro, Therm-X AT, Therm-X Pro Athlete, Zenith Technical Innovations (2018) Summary page 4.

## Most influential descendants
- 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
- K231912: Therm-X (2023), 1 descendant of its own
- K254200: Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14) (2026), 0 descendants of its own

## Indications for use
Therm-X (Therm-X Home 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 Home systems also provide DVT therapy. Therm-X Home systems with DVT therapy 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 Home 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/K193550
Methodology: https://510kreport.com/methodology