A&D UA-651BLE - Medaval

Description:

The A&D UA-651BLE is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.

Assessment:

The technology used in the A&D UA-651BLE, to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	Japanese Society of Hypertension	Self-measurement (Latest: 2016-2022)	Implied equivalence to the A&D UA-651
BP	AMA VDL (US)	Self-measurement	Equivalence claim without published evidence

	Consumer Body	Year(s)	Level	Comment
BP	Consumer Reports (US)	Latest: 2018-2021	Very Good
BP	Choice (Australia)	Previous: 2019	A

Device Family:

A&D UA-611B,J, A&D UA-651B,J,P, A&D UA-651BLEJ, A&D UA-767SB, A&D UA-767S-WB, A&D UA-651MR (UA-651A-JC11)J, A&D UA-654MR (UA-654B-JC61)J,P, A&D UA-651BLE Plus (UA-651LB-JC11)J, A&D UA-654 Plus (UA-654B-JCB1)J
Legend: B BIHS Derivative, J JHS Implied Equivalence, P Stride Equivalence

Validation Publications for Equivalent Devices:

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

A&D UA-651

Benetti E, Fania C, Palatini P. Validation of the A&D BP UA-651 device for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2014 Feb;19(1):50-3. doi: 10.1097/MBP.0000000000000020. PMID: 24346435.

ESH-IP:2010 - Pass General population

Benetti E, Fania C, Palatini P. Validation of the A&D BP UA-651 device with a wide-range cuff for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2015 Jun;20(3):164-7. Epub: 2014 Dec 22. doi: 10.1097/MBP.0000000000000100. PMID: 25536400.

ESH-IP:2010 - Pass General population