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A&D UA-767PC

Device Model:UA-767PC
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:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

While the technology used in the A&D UA-767PC, 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.
BIHS (UK and IRL)Self-measurementManufacturer declaration of equivalence
ESH (Europe)Self-measurementThe BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.
Japanese Society of HypertensionSelf-measurement (2016-2018)Implied equivalence to the A&D UA-767 Plus

Device Family:A&D UA-766J, A&D UA-767J, A&D UA-767 PlusB,J, A&D UA-767BTB, A&D UA-767PCB,J, A&D UA-767VJ, A&D UA-772KJ, A&D UA-772NFCJ, A&D UA-774B,J, A&D UA-774JJ, A&D UA-779J (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-767

Rogoza AN, Pavlova TS, Sergeeva MV. Validation of A&D UA-767 device for the self-measurement of blood pressure. Blood Press Monit. 2000 Aug;5(4):227-31. PMID: 11035865.

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

SP10:1996 - Pass General population

A&D UA-767 Plus

Кобалава ЖД, Котовская ЮВ, Бабаева ЛА, Русакова ОС. [Kobalava ZD, Kotovskaia IV, Rusakova OS, Babaeva LA.] Валидация электронного полностью автоматического прибора UA-777 (A&D, Япония) для самоконтроля АД. [Validation of UA-767 Plus device for self measurement of blood pressure.] Клиническая фармакология и терапия [Clin Pharmacol Ther]. 2003;12(2):70-2. Available from: andyte.com.

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

A&D UA-774

Verdecchia P, Angeli F, Poeta F, Reboldi GP, Borgioni C, Pittavini L, Porcellati C. Validation of the A&D UA-774 (UA-767Plus) device for self-measurement of blood pressure. Blood Press Monit. 2004 Aug;9(4):225-9. PMID: 15311150.

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

A&D UA-779

Longo D, Bertolo O, Toffanin G, Frezza P, Palatini P. Validation of the A&D UA-631 (UA-779 Life Source) device for self-measurement of blood pressure and relationship between its performance and large artery compliance. Blood Press Monit. 2002 Aug;7(4):243-8. PMID: 12198341.

ESH-IP:2002 - Pass General population