A&D UA-611
While the technology used in the A&D UA-611, 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 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 (2016-2019) | 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
