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Omron HEM-7121

Omron HEM-7121
Device Model:HEM-7121
Manufacturer:Sole: 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
Availability:Available Currently
Assessment:

The technology used in the Omron HEM-7121, 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 (2016-2020)Implied equivalence to the Omron HEM-7130, HEM-7320F or HEM-7500F
 
Consumer BodyVersionQuartileComment
Choice (Australia)2019-2020A 

Device Family:Omron HCR-7006Z, Omron HCR-7101J, Omron HCR-7102Z, Omron HCR-7104Z, Omron HCR-7106Z, Omron HCR-710YZ, Omron HCR-7201J, Omron HCR-7202Z, Omron HCR-720KZ, Omron HCR-7402Z, Omron HCR-7409J, Omron HCR-7501TJ, Omron HCR-7502TZ, Omron HCR-750ATJ, Omron HCR-7601TJ, Omron HCR-7602TZ, Omron HEM-7120J, Omron HEM-7121J, Omron HEM-7122J, Omron HEM-7130B,J,P, Omron HEM-7130-HPJ, Omron HEM-7132 (V1)J, Omron HEM-7133J, Omron HEM-7270CJ, Omron HEM-7271TJ, Omron HEM-7280CJ, Omron HEM-7281TJ, Omron HEM-7310J, Omron HEM-7313J, Omron HEM-7324CJ, Omron HEM-7325TJ, Omron HEM-7510CJ, Omron HEM-7511TJ, Omron HEM-8712J, Omron HEM-8713J, Omron HEM-8731J, Omron HEM-9200TJ, Omron HEM-9700TJ, Omron M2 (HEM-7121-E)B,P, Omron M2 Basic (HEM-7120-E)B,P, Omron M2 Eco (HEM-7120-AF)P, Omron M3 Comfort (HEM-7134)J (B BIHS Derivative, J JHS Implied Equivalence, P Stride Equivalence, Z Almost Certain)
Relevant Publications

Islam SMS, Cartledge S, Karmakar C, Rawstorn JC, Fraser SF, Chow C, Maddison R. Validation and Acceptability of a Cuffless Wrist-Worn Wearable Blood Pressure Monitoring Device Among Users and Health Care Professionals: Mixed Methods Study. JMIR Mhealth Uhealth. 2019 Sep 14;7(10):e14706. doi: 10.2196/14706. PMID: 31628788 . Available from: mhealth.jmir.org.

The publication describes the Omron HEM-7121 being used as a validation control device.

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-7130

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

Omron HEM-9700T

Kuwabara M, Harada K, Hishiki Y, Kario K. Validation of an automatic device for the self-measurement of blood pressure in sitting and supine positions according to the ANSI/AAMI/ISO81060-2: 2013 guidelines: the Omron HEM-9700T. Blood Press Monit. Epub: 2019 Feb 14. doi: 10.1097/MBP.0000000000000368.

81060-2:2013 - Pass Sitting position

81060-2:2013 - Pass Supine position