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:
Discontinued but still available
Availability according to Countries or Regions:
Japan
Description:
The A&D TM-2657VP 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. This device has been discontinued by the manufacturer but may be available through certain outlets.
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 (Previous: 2019-2023) | Implied equivalence to the A&D TM-2656 claim without published evidence |
Device Family:
A&D TM-2656B,J, A&D TM-2657J, A&D TM-2657PB,J, A&D TM-2656VPWJ, A&D TM-2657VPJ, A&D TM-2657WJ, A&D TM-2657WPJ, A&D TM-2657WVPJ
Legend: B BIHS Derivative, J JHS Implied Equivalence
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