A&D UA-1010
Device Model:
UA-1010
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 and Japan
Device Manual:
Click here to download the Device Manual
Description:
The A&D UA-1010 is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. 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-1010, to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP BIHS (UK and IRL) Self-measurement (Previous) Manufacturer declaration of equivalence to the A&D UA-1020
BP ESH (Europe) Self-measurement The BIHS recommendation, despite the absence, at the time, of the scientific evidence required by the same authors' criteria.
BP Japanese Society of Hypertension Self-measurement (Latest: 2016-2022) Implied equivalence to the A&D UA-1020
BP FDA (US) 510(k) 510(k) K111686,
Consumer BodyYear(s)LevelComment
BP Choice (Australia) Previous A
Device Family:
A&D UA-1010B,J, A&D UA-1020L,B,J,P, A&D UA-1030TL,B,J, A&D UA-1020BJ, A&D UA-1020GJ, A&D UA-1020PJ, A&D UA-1020WZ, A&D UA-611 PlusJ,P, A&D UA-651 Plus (UA-656A-JCB1)J,P, A&D UA-651SL PlusJ,P, A&D UA-1005MR (UA-1005C-JC61)J, A&D UA-1030TMR (UA-1030TG-JC11)J, A&D UA-1030T Plus (UA-1030TG-JCB1)J, A&D UA-1005 Plus (UA-1005C-JCB1)J, A&D UA-1020NDJ, A&D UA-1020E2J, A&D UA-1020CELZ, Pharmacy Choice UA-1020Z
Legend: L AHA VDL Implied Equivalence, B BIHS Derivative, J JHS Implied Equivalence, P Stride Equivalence, Z Almost Certain
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-1020

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

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)

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