A&D UA-651SL Plus

Description:

The A&D UA-651SL Plus is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the upper arm. With atrial fibrillation detection, it is intended for self-measurement and home use.

Assessment:

The technology used in the A&D UA-651SL Plus, 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 (2022)	Implied equivalence to the
BP	Stride BP	Self-measurement for adults	Equivalence claim without published evidence

Device Family:

A&D UA-1010B,J, A&D UA-1020L,B,J,P, A&D UA-1030TL,B,J, A&D UA-1020BJ, A&D UA-1020GJ, A&D UA-1020PJ, A&D UA-1020WZ, A&D UA-611 PlusJ,P, A&D UA-651 Plus (UA-656A-JCB1)J,P, A&D UA-651SL PlusJ,P, A&D UA-1005MR (UA-1005C-JC61)J, A&D UA-1030TMR (UA-1030TG-JC11)J, A&D UA-1030T Plus (UA-1030TG-JCB1)J, A&D UA-1005 Plus (UA-1005C-JCB1)J, A&D UA-1020NDJ, A&D UA-1020E2J, Pharmacy Choice UA-1020Z
Legend: L AHA VDL Implied Equivalence, B BIHS Derivative, J JHS Implied Equivalence, P Stride Equivalence, Z Almost Certain

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-1020

Zeng WF, Kang YY, Liu M, Li Y, Wang JG. Validation of the A&D UA-1020 upper-arm blood pressure monitor for home blood pressure monitoring according to the British Hypertension Society Protocol. Blood Press Monit. 2013 Jun;18(3):177-81. doi: 10.1097/MBP.0b013e32836141ca. PMID: 23571228.

BHS:1993 - Pass (A/A) With D-ring cuff

BHS:1993 - Pass (A/A) With cylindrical cuff

Zeng WF, Kang YY, Liu M, Li Y, Wang JG. Validation of the A&D UA-1020 upper-arm blood pressure monitor with six different-shaped or different-sized cuffs according to the British Hypertension Society protocol. Blood Press Monit. 2013 Oct;18(5):272-7. doi: 10.1097/MBP.0b013e32836464a3. PMID: 24013618.

BHS:1993 - Pass (A/A) General population