Omron M2 Basic (HEM-7120-E)

Device Name:M2 Basic
Device Model:HEM-7120-E
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:

While the technology used in the Omron M2 Basic (HEM-7120-E), to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNot recommendedThis device has not been clinically validated. Although equivalence to another device is claimed by the manufacturer, this has not been tested scientifically.
BIHS (UK and IRL)Self-measurementManufacturer declaration of equivalence
ESH (Europe)Self-measurementThe BIHS recommendation, despite the absence of scientific evidence according to the same authors' criteria.
 
Consumer BodyVersionQuartileComment
Which? (UK)2019A 

Device Family:Omron HEM-7130B, Omron M2 (HEM-7121-E)B (B BIHS Derivative)