Fitbit

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242967Loss of Pulse DetectionFebruary 25, 2025
K243778Body Temperature Software (BTS)February 13, 2025
DEN230050Body Temperature Software (BTS)December 15, 2023
K212372Fitbit Irregular Rhythm NotificationsApril 8, 2022
K200948Fitbit ECG AppSeptember 11, 2020
K133872ARIA WIFI SMART SCALEJune 2, 2014