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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:

While the technology used in the A&D UA-851PBT-C, to measure blood pressure, has been claimed as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but there is no evidence provided on a validation of the other device.

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