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A&D TM-2655VP

Device Model:TM-2655VP
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 use as a public facility
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Discontinued but still available
Assessment:

The technology used in the A&D TM-2655VP, 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.
Japanese Society of HypertensionSelf-measurement and professional use (2016-2019)Implied equivalence to the A&D TM-2655 or TM-2655P

Device Family:A&D TM-2440P, A&D TM-2441P, A&D TM-2655J,P, A&D TM-2655P (v2)J, A&D TM-2655VPJ (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 TM-2441

Kario K, Hoshide S, Saito K, Sato K, Hamasaki H, Suwa H, Tomitani N. Validation of the TM-2441 ambulatory blood pressure measurement device according to the ISO 81060-2 2013 standard. Blood Press Monit. 2019 Feb;24(1):38-41. Epub: 2019 Nov 29. doi: 10.1097/MBP.0000000000000357. PMID: 30507622.

81060-2:2013 - Pass General population (Note: Primary 85-subject study)

81060-2:2013 - Pass General population (Note: 35-subject exercise study, as required for ABPM devices)

Both the main and exercise studies are completed; 13 subjects were included in both studies.

A&D TM-2655

Kobalava ZD, Kotovskaya YV, Babaeva LA, Moiseev VS. Validation of TM-2655 oscillometric device for blood pressure measurement. Blood Press Monit. 2006 Apr;11(2):87-90. PMID: 16534410.

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

A&D TM-2655P (v2)

Kobalava ZD, Kotovskaya YV, Babaeva LA, Moiseev VS. Validation of TM-2655 oscillometric device for blood pressure measurement. Blood Press Monit. 2006 Apr;11(2):87-90. PMID: 16534410.

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