The Hello Heart blood pressure monitor is FDA cleared, meaning it was authorized by the FDA based on the submission of a 510(k) application. Hello Heart receives <1% complaints about device accuracy. In most cases, the issues are related to either the wrong cuff size or user error (e.g., wrong cuff position). We take device quality very seriously, and if there remains a concern for inaccurate readings, we ask users to send the monitor back to us, we replace the device, and we test the returned device.