A&D TM-2657VP

Device Model:
TM-2657VP
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
Description:
The A&D TM-2657VP 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-2657VP, 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 Assessment | Recommendation | Basis | |
BP | Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
BP | Japanese Society of Hypertension | Professional use (2019-2022) | Implied equivalence to the A&D TM-2656 |
Device Family:
A&D TM-2656J, A&D TM-2657J, A&D TM-2657PJ, A&D TM-2656VPWJ, A&D TM-2657VPJ
Legend: J JHS Implied Equivalence
Legend: 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