A&D UA-611
While the technology used in the A&D UA-611, 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 Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. | ||
| BIHS (UK and IRL) | Self-measurement | Manufacturer declaration of equivalence | ||
| ESH (Europe) | Self-measurement | The BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria. | ||
| Japanese Society of Hypertension | Self-measurement (2016-2018) | Implied equivalence to the A&D UA-651 | ||
| Consumer Body | Version | Quartile | Comment | |
| Consumer Reports (US) | 2019 | Very Good | ||
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
