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A&D TM-2433

Device Model:TM-2433
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 ambulatory blood pressure monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Intermittent measurements at specified intervals or times
Availability:Available Currently
Assessment:

While the technology used in the A&D TM-2433, to measure blood pressure, has been claimed as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but there is no evidence provided on a validation of the other device.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
Japanese Society of HypertensionSelf-measurement and professional use (2016-2019)Implied equivalence to the A&D TM-2430

Device Family:A&D TM-2430J, A&D TM-2433J (J JHS Implied 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 TM-2430

Palatini P, Frigo G, Bertolo O, Roman E, Da Cortà R, Winnicki M. Validation of the A&D TM-2430 device for ambulatory blood pressure monitoring and evaluation of performance according to subjects' characteristics. Blood Press Monit. 1998 Aug;3(4):255-60. PMID: 10212363.

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

SP10:1992 - Pass General population

Yip GW, So HK, Li AM, Tomlinson B, Wong SN, Sung RY. Validation of A&D TM-2430 upper-arm blood pressure monitor for ambulatory blood pressure monitoring in children and adolescents, according to the British Hypertension Society protocol. Blood Press Monit. 2012 Apr;17(2):76-9. doi: 10.1097/MBP.0b013e328351d4a4. PMID: 22391521.

BHS:1993 - Pass (A/B) Children and adolescents (n=61)