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Kinetik TMB-1491-S
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 AssessmentRecommendationBasis
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:
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