A&D UA-654MR (UA-654B-JC61)
Device Name:
UA-654MR
Device Model:
UA-654B-JC61
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:
Japan
Description:
The A&D UA-654MR (UA-654B-JC61) 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-654MR (UA-654B-JC61), 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 Japanese Society of Hypertension Self-measurement (Latest: 2016-2022) Implied equivalence to the A&D UA-651
BP Stride BP Self-measurement for adults (Preferred) Equivalence claim without published evidence
Device Family:
A&D UA-611B,J, A&D UA-651B,J,P, A&D UA-651BLEJ, A&D UA-767SB, A&D UA-767S-WB, A&D UA-651MR (UA-651A-JC11)J, A&D UA-654MR (UA-654B-JC61)J,P, A&D UA-651BLE Plus (UA-651LB-JC11)J, A&D UA-654 Plus (UA-654B-JCB1)J
Legend: B BIHS Derivative, J JHS Implied Equivalence, P Stride Equivalence
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

Benetti E, Fania C, Palatini P. Validation of the A&D BP UA-651 device for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2014 Feb;19(1):50-3. doi: 10.1097/MBP.0000000000000020. PMID: 24346435.

ESH-IP:2010 - Pass General population

Benetti E, Fania C, Palatini P. Validation of the A&D BP UA-651 device with a wide-range cuff for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2015 Jun;20(3):164-7. Epub: 2014 Dec 22. doi: 10.1097/MBP.0000000000000100. PMID: 25536400.

ESH-IP:2010 - Pass General population

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