Device Model:
TMB-1491-S
Manufacturer:
OBL: Alliance Unichem IP Ltd. (Alvita), 2 The Heights, Brooklands, Weybridge, Surrey KT13 0NY, UNITED KINGDOM.
OEM: Guangdong Transtek Medical Electronics Co. Ltd., Zone A, 105 Dongli Road, Torch Development District, Zhongshan 528437, CHINA.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Not made available
Description:
The Alvita TMB-1491-S 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 upper arm. It is intended for self-measurement and home use.
Assessment:
While the technology used in the Alvita TMB-1491-S, to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant 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 |
BIHS (UK and IRL) |
Self-measurement |
Manufacturer declaration of equivalence to the Transtek TMB-1491 |
Device Family:
Activ8rlives Blood Pressure 3 (TMB-1491-BS)B,
Alvita TMB-1491-SB,
Kinetik WBP1B,
Kinetik TMB-2080B,
Kinetik TMB-1491-SB,
Kinetik TMB-2083-NB,
Transtek TMB-1491B,P,
Transtek TMB-1491-SB,
Transtek TMB-2084P,
Transtek TeleRPM BPM(BLE) 2022 (TMB-2084-A (V1))P,
Transtek TMB-2084-A (V2)Z,
Transtek TMB-2084-TZLegend:
B BIHS Derivative,
P Stride Equivalence,
Z Almost Certain
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-1491
Tian H, Zeng S, Zhong X, Gong W, Liu W. Validation of Transtek blood pressure monitor TMB-1491 for self-measurement according to the European Society of Hypertension International Protocol reversion 2010. Blood Press Monit. 2015 Oct;20(5):280-2. Epub: 2015 May 5. doi: 10.1097/MBP.0000000000000125. PMID: 25968092.
ESH-IP:2010 - Pass General population
