Device Name:
Wellbeing
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 Kinetik TMB-1491-S is an automatic 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 self-measurement and home use.
Assessment:
While the technology used in the Kinetik 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 |
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
