United States
FC-BP220 Device: FDA 510(k) Cleared
Class II wrist blood pressure monitor under 510(k) K231367.
Verified medical device standards
Review documentation that applies to the FC-BP220 wrist monitor and its identified manufacturer. These documents do not represent clearance or approval of the Blood Health AI app.
United States
Class II wrist blood pressure monitor under 510(k) K231367.
European Union / EEA
Class IIa medical device under Regulation (EU) 2017/745.
United States
FC-BP220 passed applicable electromagnetic-emissions testing.
Quality management
Manufactured under a certified medical-device quality management system.
Why this matters
The FC-BP220 uses a non-invasive technique in which an inflatable cuff wraps around the wrist to measure systolic blood pressure, diastolic blood pressure, and pulse rate.
It is not a camera-based phone app or a watch-generated blood pressure estimate.
Source documents
Original regulatory and certification documents for the FC-BP220 device and its manufacturer.