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A&D TM-2655P (v2)
Device Model:
TM-2655P
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 use as a public facility
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Japan
Device Manual:
Click here to download the Device Manual
Description:
The A&D TM-2655P (v2) is a waiting-room blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the upper arm. It is intended for use as a public facility.
Assessment:
The technology used in the A&D TM-2655P (v2), to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval Legacy approval Older clinical validation; older protocol
BP ESH (Europe) Professional use A BIHS recommendation that does not exist
BP Japanese Society of Hypertension Self-measurement and professional use (Latest: 2016-2022) Published evidence
BP FDA (US) 510(k) 510(k) K010828
Device Family:
A&D TM-2655J,P, A&D TM-2655P (v2)J, A&D TM-2440B,P, A&D TM-2441B,P, A&D TM-2655VPJ
Legend: B BIHS Derivative, J JHS Implied Equivalence, P Stride Equivalence
Validation Publications:

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

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: 2018 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

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