Hingmed WBP-02A BT (V2)
Device Model:
WBP-02A BT
Manufacturer:
Hingmed Medical Instrument Co. Ltd., 4F Zhonghang Flying Industrial Park, 371 Guangshen Road, Xixiang, Bao’an District, Shenzhen, CHINA.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for ambulatory blood pressure monitoring
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Hingmed WBP-02A BT (V2) is an ambulatory blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. . It is intended for ambulatory blood pressure monitoring.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Hingmed WBP-02A BT (V2) to measure blood pressure. However, this device appears to be very similar to a validated device by the same manufacturer or a device within a family of equivalent devices, but equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
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.
Hingmed WBP-02A
Fania C, Vezzù L, Lazzaretto I, Palatini P. Validation of the Hingmed WBP-02A device for ambulatory blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2019 Jun;24(3):151-154. Epub: 2019 Feb 22. doi: 10.1097/MBP.0000000000000371. PMID: 30807305. Available from: journals.lww.com.
ESH-IP:2010 - Pass General population