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A&D UA-1030T

Device Model:UA-1030T
Manufacturer:Sole: 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 and repeated measurements
Availability:Available Currently
Assessment:

The technology used in the A&D UA-1030T, 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.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)Self-measurementManufacturer declaration of equivalence
ESH (Europe)Self-measurementThe BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.
Japanese Society of HypertensionSelf-measurement (2016-2019)Implied equivalence to the A&D UA-1020
AMA VDL CriteriaSatisfies stated criteria510(k) K111686 plus BHS:1993 validation
 
Consumer BodyVersionQuartileComment
Choice (Australia)2019B 

Device Family:A&D UA-1005MR (UA-1005C-JC61)J, A&D UA-1010B,J, A&D UA-1020B,J,P, A&D UA-1020-WZ, A&D UA-1020BJ, A&D UA-1020GJ, A&D UA-1020PJ, A&D UA-1030TB,J, A&D UA-1030TMR (UA-1030TG-JC11)J, A&D UA-611 PlusP, A&D UA-651 PlusP, A&D UA-651SL PlusP (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