A&D UA-851PBT-C - Medaval

A&D UA-851PBT-C

Device Model:

UA-851PBT-C

Manufacturer:

A&D Company Ltd., 3-23-14 Higashi-Ikebukuro, Toshima-Ku, 170-0013 Tokyo, JAPAN.

Measuring functions:

Blood pressure

Primary Client Use:

Intended for professional use

Measurement Site:

Upper Arm

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Availability according to Countries or Regions:

Japan

Description:

The A&D UA-851PBT-C 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 professional use.

Assessment:

The technology used in the A&D UA-851PBT-C, 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-851, UA-852, UA-853, UA-854 or UA-855

Device Family:

A&D UA-851B,J, A&D UA-852B,J, A&D UA-853B,J, A&D UA-854B,J, A&D UA-855B,J, A&D UA-851PBT-CJ
Legend: B BIHS Derivative, J JHS Implied 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-851

Bonso E, Ragazzo F, Palatini P. Validation of A&D UA-85X device for blood pressure measurement. Blood Press Monit. 2008 Dec;13(6):339-41. doi: 10.1097/MBP.0b013e32830d4b77. PMID: 19020424.

ESH-IP:2002 - Pass General population

SP10:1987 - Pass General population

A&D UA-852

Bonso E, Ragazzo F, Palatini P. Validation of A&D UA-85X device for blood pressure measurement. Blood Press Monit. 2008 Dec;13(6):339-41. doi: 10.1097/MBP.0b013e32830d4b77. PMID: 19020424.

ESH-IP:2002 - Pass General population

SP10:1987 - Pass General population

A&D UA-853

Bonso E, Ragazzo F, Palatini P. Validation of A&D UA-85X device for blood pressure measurement. Blood Press Monit. 2008 Dec;13(6):339-41. doi: 10.1097/MBP.0b013e32830d4b77. PMID: 19020424.

ESH-IP:2002 - Pass General population

SP10:1987 - Pass General population

A&D UA-854

Bonso E, Ragazzo F, Palatini P. Validation of A&D UA-85X device for blood pressure measurement. Blood Press Monit. 2008 Dec;13(6):339-41. doi: 10.1097/MBP.0b013e32830d4b77. PMID: 19020424.

ESH-IP:2002 - Pass General population

SP10:1987 - Pass General population

A&D UA-855

Bonso E, Ragazzo F, Palatini P. Validation of A&D UA-85X device for blood pressure measurement. Blood Press Monit. 2008 Dec;13(6):339-41. doi: 10.1097/MBP.0b013e32830d4b77. PMID: 19020424.

ESH-IP:2002 - Pass General population

SP10:1987 - Pass General population