Andon KD-723
Device Model:
KD-723
Manufacturer:
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:
Wrist
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Device Specifications:
Description:
The Andon KD-723 is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.
Assessment:
The technology used in the Andon KD-723, to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance 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. |
| BP | Stride BP | Self-measurement for adults | Equivalence claim without published evidence |
Device Family:
Andon KD-723P, iHealth Sense BP7 (KD-972)B,P, iHealth View (BP7S)B,P
Legend: B BIHS Derivative, P Stride Equivalence
Legend: B BIHS Derivative, P Stride Equivalence
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.
iHealth Sense BP7 (KD-972)
Wang Q, Zhao H, Chen W, Li N, Wan Y. Validation of the iHealth BP7 wrist blood pressure monitor, for self-measurement, according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2014 Feb;19(1):54-7. doi: 10.1097/MBP.0000000000000017. PMID: 24361919.
ESH-IP:2010 - Pass General population