A&D UA-1020
Device Model:
UA-1020
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:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Australia, Ireland, Japan and United States
Device Manual:
Description:
The A&D UA-1020 is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 1-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-1020, to measure blood pressure, has passed in three clinical validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval Recommendation Older clinical validation; older protocol; multiple clinical validations
BP BIHS (UK and IRL) Self-measurement (Previous) Published evidence
BP ESH (Europe) Self-measurement The BIHS recommendation
BP Japanese Society of Hypertension Self-measurement (Latest: 2016-2022) Published evidence
BP Stride BP Self-measurement for adults Published evidence
BP AMA VDL (US) Self-measurement Implied equivalence to the A&D UA-1030T plus 510(k) K111686,
BP FDA (US) 510(k) 510(k) K111686,
Device Family:
Validation Publications:

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

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 UA-651 Plus (UA-656A-JCB1)

Alpert BS. Validation of the A&D UA-651 Plus/UA-651SL Plus automated sphygmomanometer according to the ISO 81060-2, 2018 and ISO 81060-2 Amendment 1, 2020, which resulted in the currently pending Amendment to Amendment 1. J Clin Hypertens (Greenwich). 2022 Apr;24(4):513-518. Epub: 2022 Mar 21. doi: 10.1111/jch.14464. PMID: 35312160. Available from: PMC8989751.

81060-2:2020 - Pass (n=85)

A&D UA-651SL Plus

Alpert BS. Validation of the A&D UA-651 Plus/UA-651SL Plus automated sphygmomanometer according to the ISO 81060-2, 2018 and ISO 81060-2 Amendment 1, 2020, which resulted in the currently pending Amendment to Amendment 1. J Clin Hypertens (Greenwich). 2022 Apr;24(4):513-518. Epub: 2022 Mar 21. doi: 10.1111/jch.14464. PMID: 35312160. Available from: PMC8989751.

81060-2:2020 - Pass (n=85)