Home /  A&D UA-767BT

A&D UA-767BT

Device Model:UA-767BT
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-767BT, to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant 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.
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.
AMA VDL CriteriaSatisfies stated criteria510(k) K040371 plus BHS:1993 validation

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