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A&D UB-510

Device Model:UB-510
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 self-measurement and home use
Measurement Site:Wrist
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the A&D UB-510, 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 (2018)Implied equivalence to the A&D UB-511 or UB-512

Device Family:A&D UB-510J, A&D UB-511J, A&D UB-511LJ, A&D UB-512J, A&D UB-512HJ (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 UB-511

Angeli F, Sardone M, Angeli E, Repaci S, Gattobigio R, Verdecchia P. Validation of the A&D wrist-cuff UB-511 (UB-512) device for self-measurement of blood pressure. Blood Press Monit. 2006 Dec;11(6):349-54. PMID: 17106320.

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

A&D UB-512

Angeli F, Sardone M, Angeli E, Repaci S, Gattobigio R, Verdecchia P. Validation of the A&D wrist-cuff UB-511 (UB-512) device for self-measurement of blood pressure. Blood Press Monit. 2006 Dec;11(6):349-54. PMID: 17106320.

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