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:

Click here to download the 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 Assessment	Recommendation	Basis
BP	Medaval	★★ Recommendation	Recent clinical validation; older protocol; multiple clinical validations
BP	DHL (DE)	General use (Previous: 2012, 2014, 2016)	Published evidence plus equivalence claim
BP	ESH (Europe)	Self-measurement	The DHL recommendation

	Consumer Body	Year(s)	Level	Comment
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)