YaHorng BP-500
Device Model:
BP-500
Manufacturer:
Brand: YaHorng Electronic Co. Ltd., 35 Shalun, Anding District, Tainan City 745, TAIWAN ROC.
Measuring functions:
Blood Pressure and PR
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Wrist
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The YaHorng BP-500 is an automatic oscillometric (pendant le gonflage) blood pressure monitor. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.
Assessment:
The technology used in the YaHorng BP-500, to measure blood pressure, has been declared as being substantially equivalent to that used in another device, according to 510(k), but this is not compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | Not recommended | This device has not been shown to have been clinically validated. |
Device Family:
YaHorng BP-500F, YaHorng BP-510F, YaHorng BP-700F, YaHorng BP-700TF, YaHorng BP-700TBF, YaHorng BP-700TUBF, YaHorng BP-700UBF, YaHorng BP-700WF
Legend: F FDA 510(k)
Legend: F FDA 510(k)