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A&D UA-767FAM
Device Model:
UA-767FAM
Manufacturer:
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
Availability according to Countries or Regions:
Canada
Device Manual:
Click here to download the Device Manual
Description:
The A&D UA-767FAM is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the A&D UA-767FAM to measure blood pressure. However, this device appears to be very similar to a validated device by the same manufacturer or a device within a family of equivalent devices, but equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP Hypertension Canada Self-measurement (Gold) Manufacturer declaration of equivalence
Device Family:
A&D UA-767J, A&D UA-767 PlusB,J, A&D UA-767 Plus 30Z, A&D UA-767FZ, A&D UA-767FACZ, A&D UA-767PBT-CiZ, A&D UA-767PSACZ, A&D UA-767PVSZ, A&D UA-774B,J, A&D UA-779J, A&D UA-767NFCZ, A&D UA-767BTB, A&D UA-767PCB,J, A&D UA-767TZ, A&D UA-767FAMZ, A&D UA-767PZ, A&D UA-767PCNZ, A&D UA-767PCNLZ, A&D UA-767PCNSZ, A&D UA-767PLACZ, A&D UA-767PVZ, A&D UA-767PVLZ, A&D UA-766J, A&D UA-767VJ, A&D UA-772KJ, A&D UA-772NFCJ, A&D UA-774JJ, A&D UA-767F-WZ, A&D UA-767JPZ, A&D UA-767PCNACZ, A&D UA-767PCNLACZ, A&D UA-767PCNSACZ
Legend: B BIHS Derivative, J JHS Implied Equivalence, Z Almost Certain
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

SP10:1992 - 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

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