Omron HBP-9030
Device Model:
HBP-9030
Manufacturer:
Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for use as a public facility
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Japan
Description:
The Omron HBP-9030 is a waiting-room 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 upper arm. It is intended for use as a public facility.
Assessment:
The technology used in the Omron HBP-9030, 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 | Japanese Society of Hypertension | Professional use (Latest: 2021-2022) | Implied equivalence to the Omron HBP-9031C |
| BP | Stride BP | Office use for adults (Preferred) | Equivalence claim without published evidence |
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.
Omron HBP-9031C
Saito K, Hishiki Y, Takahashi H. Validation of the Omron HBP-9031C professional office blood pressure monitor in the general population according to the ANSI/AAMI/ISO 81060-2:2013 protocol. J Hum Hypertens. 2020 Oct;34(10):735-738. Epub: 2020 Jan 22. doi: 10.1038/s41371-020-0301-0. PMID: 31969675.
81060-2:2013 - Pass General population