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A&D UA-851PBT-C

Device Model:UA-851PBT-C
Manufacturer:Sole: 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
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.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
Japanese Society of HypertensionSelf-measurement (2016-2019)Implied equivalence to the A&D UA-851, UA-852, UA-853, UA-854 or UA-855

Device Family:A&D UA-851B, A&D UA-851PBT-CJ, A&D UA-852B,J, A&D UA-853B,J, A&D UA-854B,J, A&D UA-855B,J (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