A&D UA-1030T
The technology used in the A&D UA-1030T, to measure blood pressure, has been compared to a clinically validated device but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance 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 (2016-2019) | Implied equivalence to the A&D UA-1020 | ||
| AMA VDL Criteria | Satisfies stated criteria | 510(k) K111686 plus BHS:1993 validation | ||
| Consumer Body | Version | Quartile | Comment | |
| Choice (Australia) | 2019 | B | ||
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-1020
Zeng WF, Kang YY, Liu M, Li Y, Wang JG. Validation of the A&D UA-1020 upper-arm blood pressure monitor for home blood pressure monitoring according to the British Hypertension Society Protocol. Blood Press Monit. 2013 Jun;18(3):177-81. doi: 10.1097/MBP.0b013e32836141ca. PMID: 23571228.
BHS:1993 - Pass (A/A) With D-ring cuff
BHS:1993 - Pass (A/A) With cylindrical cuff
Zeng WF, Kang YY, Liu M, Li Y, Wang JG. Validation of the A&D UA-1020 upper-arm blood pressure monitor with six different-shaped or different-sized cuffs according to the British Hypertension Society protocol. Blood Press Monit. 2013 Oct;18(5):272-7. doi: 10.1097/MBP.0b013e32836464a3. PMID: 24013618.
BHS:1993 - Pass (A/A) General population
