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Omron M400 (HEM-7131-D)
Device Name:
M400
Device Model:
HEM-7131-D
Manufacturer:

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

Other: Omron Healthcare Manufacturing Vietnam Co. Ltd., 28 VSIP II, Street 2, Vietnam-Singapore Industrial Park II, Hoa Phu Ward, Thu Dau Mot City, Binh Duong Province 820000, VIET NAM.

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
Availability according to Countries or Regions:
Germany and Ireland
Device Manual:
Description:
The Omron M400 (HEM-7131-D) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 2-star Medaval rating. 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 M400 (HEM-7131-D), to measure blood pressure, has passed in two clinical validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval ★★ Recommendation Recent clinical validation; older protocol; multiple clinical validations
BP DHL (DE) General use (2012, 2014, 2016) Published evidence plus equivalence claim
BP ESH (Europe) Self-measurement The DHL recommendation
Consumer BodyYear(s)LevelComment
BP Stiftung Warentest (DE) Previous: 2018 Satisfactory
Validation Publications:

Tholl U, Lüders S, Bramlage P, Dechend R, Eckert S, Mengden T, Nürnberger J, Sanner B, Anlauf M. The German Hypertension League (Deutsche Hochdruckliga) Quality Seal Protocol for blood pressure-measuring devices: 15-year experience and results from 105 devices for home blood pressure control. Blood Press Monit. 2016 Aug;22(4):197-205. doi: 10.1097/MBP.0000000000000186. PMID: 26998590.

DHL:2007 - Pass General population (Note: 2012)

DHL:2007 - Pass General population (Note: 2014)