Home /  Omron HEM-1021

Omron HEM-1021

Device Model:HEM-1021
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:

The technology used in the Omron HEM-1021, 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.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
Japanese Society of HypertensionSelf-measurement (2017-2019)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