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Yonker YK-BPA2 (V3)
Device Model:
YK-BPA2
Manufacturer:
Xuzhou Yongkang Electronic Technology Co. Ltd. (Yonker), 4F C8 Building, Science Development Area, 40 Jingshan Road, Economic Development District, Xuzhou, Jiangsu, 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:
Available Currently
Description:
The Yonker YK-BPA2 (V3) is an automatic blood pressure monitor. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology. 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 Yonker YK-BPA2 (V3), to measure blood pressure, has been declared, on the manufacturer website, 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 Not recommended This device has not been shown to have been clinically validated.
Device Family:
Combei BP606WY, Juning BP606WZ, Medisana BW 315 (51072)Y, OxiPro BP1Y, Yonker YK-BPA2 (V3)Y
Legend: Y Internal declaration, Z Almost Certain