Fitbit is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Fitbit - FDA 510(k) Cleared Devices
Recent clearances: Loss of Pulse Detection
1
Total
1
Cleared
0
Denied
Fitbit has 1 FDA 510(k) cleared medical devices. Based in San Francisco, US.
Latest FDA clearance: Feb 2025. Active since 2025. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Fitbit Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Fitbit
1 devices