Zenith Technical Innovations
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K240125 | Therm-X (Home); Therm-X (AT) | June 21, 2024 |
| K231912 | Therm-X | July 27, 2023 |
| K193550 | Therm-X | February 28, 2020 |
| K190854 | Therm-X | May 10, 2019 |
| K181149 | Therm-X Pro, Therm-X AT, Therm-X Pro Athlete | August 3, 2018 |