Zenith Technical Innovations

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K240125Therm-X (Home); Therm-X (AT)June 21, 2024
K231912Therm-XJuly 27, 2023
K193550Therm-XFebruary 28, 2020
K190854Therm-XMay 10, 2019
K181149Therm-X Pro, Therm-X AT, Therm-X Pro AthleteAugust 3, 2018