Omron J761 (HEM-7600T-SH3BK)
Device Name:
J761
Device Model:
HEM-7600T-SH3BK
Manufacturer:
Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Connected Health Technologies:
Bluetooth
Availability:
Available Currently
Availability according to Countries or Regions:
China
Description:
The Omron J761 (HEM-7600T-SH3BK) 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 upper arm. It is intended for self-measurement and home use.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Omron J761 (HEM-7600T-SH3BK) 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.
Omron J760 (HEM-7600T-SH3W)
Chen B, Chen G, Jiang H, Sun Y, Chen J, Wang D, Chen M, Shi J, Peng Y, Cheng Y, Yang C, Ding Y, Su J, Liu M, Shen F, Qiu Y, Shen Y, Cao Q, Su J. Validating the accuracy of Omron J760 electronic blood pressure monitor in the general population according to AAMI/ESH/ISO (ISO 81060-2:2018) + AMD1:2020. Blood Press. 2025;34(1):2469264. Epub: 2025 Feb 25. doi: 10.1080/08037051.2025.2469264. PMID: 39989294.
81060-2:2020 - Pass General population