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Omron M6 Comfort (HEM-7321-E)

Device Name:M6 Comfort
Device Model:HEM-7321-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

The technology used in the Omron M6 Comfort (HEM-7321-E), to measure blood pressure, is among the best rated for accuracy by Medaval Ltd. It has passed in two clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.

Accuracy AssessmentRecommendationBasis
Medaval★★★ RecommendationRecent clinical validation; recent protocol; multiple clinical validations
ESH (Europe)Self-measurementPublished evidence

Device Family:Omron M6 Comfort IT (HEM-7322U-E)D (D DET Equivalence)
Validation Publications

Belghazi J, El Feghali RN, Moussalem T, Rejdych M, Asmar RG. Validation of four automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension. Vasc Health Risk Manag. 2007;3(4):389-400. PMID: 17969368. Available from: PMC2291343.

ESH-IP:2002 - Pass General population

Relevant Publications

Bilo G, Sala O, Perego C, Faini A, Gao L, Głuszewska A, Ochoa JE, Pellegrini D, Lonati LM, Parati G. Impact of cuff positioning on blood pressure measurement accuracy: may a specially designed cuff make a difference? Hypertens Res. 2017 Jun;40(6):573-80. Epub: 2017 Jan 12. doi: 10.1038/hr.2016.184. PMID: 28077860.

Measurements from the Omron M6 Comfort (HEM-7321-E) are compared to those from the ERKA "Ecometer New" (Cannot find this device on ERKA website), though not in a formal validation.

Semi-rigid IntelliWrap Cuff (HEM-FL31-E) used

Validation Publications for Equivalent Devices

Note: Provisional list; equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) not proven

Omron M6 Comfort IT (HEM-7322U-E)

Chahine MN, Topouchian J, Zelveian P, Hakobyan Z, Melkonyan A, Azaki A, Diab R, Harb A, Asmar R. Validation of BP devices QardioArm® in the general population and Omron M6 Comfort® in type II diabetic patients according to the European Society of Hypertension International Protocol (ESH-IP). Med Devices (Auckl). 2017 Dec 27;11:11-20. doi: 10.2147/MDER.S142126. PMID: 29343992. Available from: PMC5749560. eCollection 2018.

ESH-IP:2010 - Pass General population