A&D UA-1200BLE
Assessment:
The technology used in the A&D UA-1200BLE, 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 | ★★ Recommendation | Recent clinical validation; recent protocol | ||
| AMA VDL Criteria | General use | 510(k) K163683 plus 81060-2:2013 validation | ||
| MDR Criteria | Self-measurement | Published evidence | ||
Validation Publications
Kario K, Saito K, Sato K, Hamasaki H, Suwa H, Okura A, Hoshide S. Validation of the A&D BP UA-1200BLE device for home blood pressure measurement according to the ISO 81060-2: 2013 standard. Blood Press Monit. 2018 Dec;23(6):312-314. Epub: 2018 Sep 7. doi: 10.1097/MBP.0000000000000347. PMID: 30199378.
81060-2:2013 - Pass General population
