Omron HCR-750AT

Device Model:

HCR-750AT

Manufacturer:

Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.

Measuring functions:

Blood Pressure and PR

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Upper Arm

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Availability according to Countries or Regions:

Japan

Description:

The Omron HCR-750AT 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:

The technology used in the Omron HCR-750AT, 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	Self-measurement (Previous: 2019-2022)	Implied equivalence to the Omron HEM-7130, HEM-7320F or HEM-7500F

Device Family:

Omron HEM-7500FJ, Omron HEM-7510CJ, Omron HEM-7511TJ, Omron HCR-750ATJ, Omron HCR-7601TJ, Omron HCR-761AT2J, Omron HCR-7711T2J, Omron HCR-7712T2J
Legend: J JHS Implied 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.

Omron HEM-7500F

Takahashi H, Yoshika M, Yokoi T. Validation of three automatic devices for the self-measurement of blood pressure according to the European Society of Hypertension International Protocol revision 2010: the Omron HEM-7130, HEM-7320F, and HEM-7500F. Blood Press Monit. 2015 Apr;20(2):92-7. doi: 10.1097/MBP.0000000000000096. PMID: 25462531.

ESH-IP:2010 - Pass General population