A&D UB-512
The technology used in the A&D UB-512, to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | Legacy approval | Older clinical validation; older protocol | ||
| Japanese Society of Hypertension | Self-measurement (2018) | Published evidence | ||
| AMA VDL Criteria | Satisfies stated criteria | 510(k) K042967 plus BHS:1993 validation | ||
Angeli F, Sardone M, Angeli E, Repaci S, Gattobigio R, Verdecchia P. Validation of the A&D wrist-cuff UB-511 (UB-512) device for self-measurement of blood pressure. Blood Press Monit. 2006 Dec;11(6):349-54. PMID: 17106320.
BHS:1993 - Pass (B/B) General population
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 UB-511
Angeli F, Sardone M, Angeli E, Repaci S, Gattobigio R, Verdecchia P. Validation of the A&D wrist-cuff UB-511 (UB-512) device for self-measurement of blood pressure. Blood Press Monit. 2006 Dec;11(6):349-54. PMID: 17106320.
BHS:1993 - Pass (B/B) General population
