Withings - FDA 510(k) Cleared Devices

Withings, is a digital health company that designs and manufactures connected medical devices for consumer health monitoring. The company develops smart scales, wearable watches, blood pressure monitors, and specialized health tracking devices. Withings operates with a manufacturing facility in Hsin Chu City, Taiwan.

The company has received 7 FDA 510(k) clearances from 7 total submissions, with no denied submissions on record. Cardiovascular devices represent 71% of submissions, reflecting the company's core focus on heart health monitoring and blood pressure management. Withings achieved its first FDA clearance in 2011 and its most recent clearance in 2025, demonstrating sustained regulatory activity and ongoing product innovation.

The company's cleared device portfolio includes Cardiovascular monitors such as the BeamO MultiScan device, ECG applications, and blood pressure monitors. Withings also offers devices in anesthesiology and general hospital settings. The product line emphasizes clinically validated measurements integrated into consumer-friendly wearables and home health devices.

Explore the complete list of Withings FDA 510(k) cleared devices, including device names, product codes, and clearance dates in the database.

2 devices have linked clinical trials registered on ClinicalTrials.gov.