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Omron HEM-1025

Device Model:HEM-1025
Manufacturer:Sole: 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
Assessment:

While the technology used in the Omron HEM-1025, to measure blood pressure, has been claimed as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but there is no evidence provided on a validation of the other device.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
Japanese Society of HypertensionSelf-measurement (2016-2018)Implied equivalence to the Omron HEM-1020 or i-Q132 SpotArm (HEM-1010-E)

Device Family:Omron HEM-1000J, Omron HEM-1010J, Omron HEM-1011J, Omron HEM-1020J, Omron HEM-1021J, Omron HEM-1025J (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-1020

Takahashi H, Yoshika M, Yokoi T. Validation of home blood pressure-monitoring devices, Omron HEM-1020 and Omron i-Q132 (HEM-1010-E), according to the European Society of Hypertension International Protocol. Blood Press Monit. 2011 Aug;16(4):203-7. doi: 10.1097/MBP.0b013e328348b688. PMID: 21701384.

ESH-IP:2002 - Pass General population