Device Model:
UA-767S
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:
Australia and Ireland
Device Manual:
Device Specifications:
Description:
The A&D UA-767S 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:
While the technology used in the A&D UA-767S, 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.
Recommendations:
| Accuracy Assessment | Recommendation | Basis |
| BP |
Medaval |
None |
Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
| BP |
BIHS (UK and IRL) |
Self-measurement |
Manufacturer declaration of equivalence to the A&D UA-651 |
Device Family:
A&D UA-611B,J,
A&D UA-651B,J,P,
A&D UA-651BLEJ,
A&D UA-767SB,
A&D UA-767S-WB,
A&D UA-651MR (UA-651A-JC11)J,
A&D UA-654MR (UA-654B-JC61)J,P,
A&D UA-651BLE Plus (UA-651LB-JC11)J,
A&D UA-654 Plus (UA-654B-JCB1)JLegend:
B BIHS Derivative,
J JHS Implied Equivalence,
P Stride 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-651
Benetti E, Fania C, Palatini P. Validation of the A&D BP UA-651 device for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2014 Feb;19(1):50-3. doi: 10.1097/MBP.0000000000000020. PMID: 24346435.
ESH-IP:2010 - Pass General population
Benetti E, Fania C, Palatini P. Validation of the A&D BP UA-651 device with a wide-range cuff for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2015 Jun;20(3):164-7. Epub: 2014 Dec 22. doi: 10.1097/MBP.0000000000000100. PMID: 25536400.
ESH-IP:2010 - Pass General population
