A&D UB-512

Device Model:

UB-512

Manufacturer:

A&D Company Ltd., 3-23-14 Higashi-Ikebukuro, Toshima-Ku, 170-0013 Tokyo, JAPAN.

Measuring functions:

Blood pressure

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Wrist

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Availability according to Countries or Regions:

Australia and Japan

Device Manual:

Click here to download the Device Manual

Description:

The A&D UB-512 is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.

Assessment:

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.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	Legacy approval	Older clinical validation; older protocol
BP	Japanese Society of Hypertension	Self-measurement (Previous: 2018)	Published evidence
BP	FDA (US)	510(k)	510(k) K042967

Device Family:

A&D UB-510J, A&D UB-511J, A&D UB-512J, A&D UB-511LJ, A&D UB-512HJ
Legend: J JHS Implied Equivalence

Validation Publications:

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

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.

A&D UB-511

BHS:1993 - Pass (B/B) General population