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Kinetik WBP1

Device Name:WBP1
Manufacturer:Kinetik Medical Devices Limited, Lockeridge House, Lockeridge, Marlborough, Wiltshire SN8 4EL, UNITED KINGDOM.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

While the technology used in the Kinetik WBP1, 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.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)Self-measurementManufacturer declaration of equivalence

Device Family:Kinetik WBP1B, Transtek TMB-1491B (B BIHS Derivative)
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