Andon KD-5918

Device Name:KD-5918
Device Model:KP-5918
Manufacturer:Sole: Andon Health Co. Ltd., 3 Jinping Road, Ya'an Street, Nankai District, Tianjin 300190, CHINA.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Device Accessibility:Voiced instructions and results
Availability:Available Currently
Assessment:

While the technology used in the Andon KD-5918, 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
MedavalNot recommendedThis device has not been clinically validated. Although equivalence to another device is claimed by the manufacturer, this has not been tested scientifically.
BIHS (UK and IRL)Self-measurementManufacturer declaration of equivalence
ESH (Europe)Self-measurementThe BIHS recommendation, despite the absence of scientific evidence according to the same authors' criteria.