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A&D TM-2657P
Device Model:
TM-2657P
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:
Australia, Canada, Ireland and Japan
Device Manual:
Description:
The A&D TM-2657P is a waiting-room 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 use as a public facility.
Assessment:
The technology used in the A&D TM-2657P, 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 BIHS (UK and IRL) Self-measurement and professional use Manufacturer declaration of equivalence
BP Hypertension Canada Public use (Gold) Manufacturer declaration of equivalence
BP Japanese Society of Hypertension Professional use (2019-2022) Implied equivalence to the A&D TM-2656
Device Family:
A&D TM-2656B,J, A&D TM-2657J, A&D TM-2657PB,J, A&D TM-2656VPWJ, A&D TM-2657VPJ
Legend: B BIHS Derivative, 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-2656

Zeng WF, Liu M, Kang YY, Li Y, Wang JG. Validation of the fully automated A&D TM-2656 blood pressure monitor according to the British Hypertension Society Protocol. Blood Press Monit. 2013 Aug;18(4):223-6. doi: 10.1097/MBP.0b013e3283624abd. PMID: 23681206.

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