Transtek TMB-1581-ZY
Device Model:
TMB-1581-ZY
Manufacturer:
Guangdong Transtek Medical Electronics Co. Ltd., Zone A, 105 Dongli Road, Torch Development District, Zhongshan 528437, CHINA.
Measuring functions:
Blood Pressure and PR
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Wrist
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Transtek TMB-1581-ZY is an automatic 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 wrist. It is intended for self-measurement and home use.
Assessment:
The technology used in the Transtek TMB-1581-ZY, 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 | Stride BP | Self-measurement for adults | Equivalence to the Transtek TMB-2285-BT claim without published evidence |
Device Family:
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.
Transtek TMB-2285-BT
Xie Z, Peng B, Hu J, Wang X, Du X, Li C, Liang J. Validation of TMB-2285-BT wrist blood pressure monitor in general population according to the ISO 81060-2:2018 + Amd.1:2020 Protocol. Blood Press Monit. 2025 Feb 1;30(1):44-47. Epub: 2024 Sep 13. doi: 10.1097/MBP.0000000000000724. PMID: 39279437.
81060-2:2018/Amd 1:2020 - Pass General population