A&D UA-1200BLE - Medaval

Description:

The A&D UA-1200BLE is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.

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.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	★★ Recommendation	Recent clinical validation; recent protocol
BP	Japanese Society of Hypertension	Self-measurement (Latest: 2021-2022)	Published evidence
BP	Stride BP	Self-measurement for adults (Preferred)	Published evidence
BP	AMA VDL (US)	Self-measurement	Published evidence plus 510(k) K163683
BP	FDA (US)	510(k)	510(k) K163683
BP	MDR Criteria	Self-measurement	Published evidence

Device Family:

A&D UA-1200CNBLE - 1200 UltraConnectZ, A&D UA-1200BLEZ, Hingmed DBP-01HPF, Hingmed DBP-01PF
Legend: F FDA 510(k), Z Almost Certain

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

Validation Publications for Equivalent Devices:

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.

Hingmed DBP-01P

Fania C, Giletto A, Zanello V, Palatini P. Validation of the Hingmed DBP-01P clinical automatic blood pressure monitor provided with wide-range cuff, evaluated in a general population according to the ISO 81060-2:2018 protocol. Blood Press Monit. 2023 Apr 1;28(2):116-120. Epub: 2023 Feb 17. doi: 10.1097/MBP.0000000000000638. PMID: 36916471.

81060-2:2019 - Pass General population