Withings

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1280-2023Class IIScan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that recordsDecember 19, 2022
Z-2829-2018Class IINokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invaJune 11, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K252474Withings BeamO (SCT02)November 10, 2025
K240795Withings ECG AppJune 15, 2025
K231667Withings Sleep RxSeptember 6, 2024
K230812Withings Scan Monitor 2.0August 23, 2023
K201456Scan MonitorOctober 5, 2021
K160544Withings Thermo (Model SCT01)June 17, 2016
K133125WITHINGS BLOOD PRESURE MONITORMarch 24, 2014
K110872WITHINGS BLOOD PRESSURE MONITORMay 20, 2011