# Zenith Technical Innovations

- Location (FDA's records): Gurnee, IL
- FDA decisions: 5 (2018–2024): 5 510(k) clearances
- Product codes: IRP (4), JOW (1)
- 510(k) review time since 2016: median 70 days, against 143 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 12 (5 its own); citations of its devices by later devices: 9 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Thermotek, Inc.: 3 (https://510kreport.com/company/thermotek)
- Cool Systems, Inc. (Dba Game Ready): 2 (https://510kreport.com/company/cool-systems-dba-game-ready)
- Coolsystems, Inc.: 1 (https://510kreport.com/company/coolsystems)
- Bio Compression Systems, Inc.: 1 (https://510kreport.com/company/bio-compression-systems)

## Firms that cite its devices most
- Jkh Health Co., Ltd.: 2 (https://510kreport.com/company/jkh-health)
- Medella Health Limited: 1 (https://510kreport.com/company/medella-health)
- Suzhou Microport Rehabtech (Group) Co., Ltd.: 1 (https://510kreport.com/company/suzhou-microport-rehabtech-group)

## Its most-cited devices
- K193550: Therm-X (2020), cited by 5
- K181149: Therm-X Pro, Therm-X AT, Therm-X Pro Athlete (2018), cited by 2
- K190854: Therm-X (2019), cited by 1
- K231912: Therm-X (2023), cited by 1

## Recent decisions
- K240125: Therm-X (Home); Therm-X (AT) (Jun 21, 2024)
- K231912: Therm-X (Jul 27, 2023)
- K193550: Therm-X (Feb 28, 2020)
- K190854: Therm-X (May 10, 2019)
- K181149: Therm-X Pro, Therm-X AT, Therm-X Pro Athlete (Aug 3, 2018)

Source page: https://510kreport.com/company/zenith-technical-innovations