A&D TM-2657

Device Model:

TM-2657

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-2657 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-2657, 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 (Latest: 2019-2022)	Non-compliant (to MEDDEV 2.7/1 rev 4) 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