QardioArm is a regulated medical device: FDA cleared, European CE marked, Canadian CE marked, and Australian TGA cleared.
You can find the 510(k) Summary of Safety and Effectiveness for QardioArm here.
QardioArm is a highly accurate blood pressure monitor and has undergone independent, formal clinical validation according to ANSI/AAMI/ISO 81060-1:2007, ANSI/AAMI/ISO 81060-2:2009, ANSI/AAMI/IEC 80601-2-30:2009, as well as British Standard EN 1060-4:2004.
QardioArm has been validated to meet the ESH - International Protocol Revision 2010 as confirmed on the DABL website here.
You can find a direct link to the ESH - International Protocol Revision 2010 validation paper here: Validation of the QardioArm
QardioArm is also listed as a validated blood pressure monitor by the British Hypertension Society: Validated BP monitors
Learn more about QardioArm accuracy here.
Learn more about QardioArm blood pressure monitor.