Omron M7 Intelli IT (HEM-7320)
Device Name:
M7 Intelli IT
Device Model:
HEM-7320
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:
Australia and United States
Device Manual:
Click here to download the Device Manual
Description:
The Omron M7 Intelli IT (HEM-7320) is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. 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 M7 Intelli IT (HEM-7320), to measure blood pressure, has been declared as being substantially equivalent to that used in another device, according to 510(k), but this is not compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP AMA VDL (US) Self-measurement Not listed explicitly but referenced for equivalence plus 510(k) K133383
BP FDA (US) 510(k) 510(k) K133383
Consumer BodyYear(s)LevelComment
BP Choice (Australia) Latest: 2019-2022 A
Device Family:
Omron M7 Intelli IT (HEM-7320)F, Omron HEM-9210T (HEM-9210T-E)F, Omron BP742 (HEM-7200-Z)F, Omron BP7900 (HEM-7530T-Z)F, Ranor RN-032AF, Ranor RN-032A-blackF, Ranor RN-032CF, Yuwell YE650A (V1)F, Yuwell YE670A (V1)F, Yuwell YE670DF, Yuwell YE660BF, Yuwell YE650D (V1)F
Legend: F FDA 510(k)
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-9210T (HEM-9210T-E)

Alpert BS. Validation of the Omron HEM-9210T by the ANSI/AAMI/ISO 81060-2:2013 with two novel cuffs: wide-range and extra-large. Blood Press Monit. 2017 Jun;22(3):166-8. Epub: 2017 Mar 1. doi: 10.1097/MBP.0000000000000250. PMID: 28252519.

81060-2:2013 - Pass General population

Van Den Heuvel JFM, Lely AT, Franx A, Bekker MN. Validation of the iHealth Track and Omron HEM-9210T automated blood pressure devices for use in pregnancy. Pregnancy Hypertens. 2019 Jan;15:37-41. Epub: 2018 Nov 2. doi: 10.1016/j.preghy.2018.10.008. PMID: 30825925.

ESH-IP:2010 - Pass Pregnancy (n=33), Pre-eclampsia (n=10)

Takahashi H. Validation of Home Blood Pressure-monitoring Devices Omron EVOLV (HEM-7600T-E), HEM-9210T, and M3 Comfort (HEM-7134-E) According to European Society of Hypertension International Protocol (ESH-IP) Revision 2010. J Clin Physiol (Jpn). 2019 Feb 1;49(1):37-46. doi: 10.34363/jocp.49.1_37. Available from: www.jstage.jst.go.jp.

ESH-IP:2010 - Pass General population

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