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Omron HEM-9210T (HEM-9210T-E)
Device Name:
HEM-9210T
Device Model:
HEM-9210T-E
Manufacturer:
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
Availability according to Countries or Regions:
United States
Description:
The Omron HEM-9210T (HEM-9210T-E) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 3-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 HEM-9210T (HEM-9210T-E), to measure blood pressure, is among the best rated for accuracy by Medaval Ltd. It has passed in three clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval ★★★ Recommendation Recent clinical validation; recent protocol; multiple clinical validations
BP BIHS (UK and IRL) NOT recommended; previous publication now retracted. (Previous) Published evidence
BP ESH (Europe) Self-measurement Published evidence
BP Stride BP Self-measurement for adults and pregnancy (Unavailable) (Preferred) Published evidence
BP AMA VDL (US) Self-measurement Published evidence plus 510(k) K163235
BP FDA (US) 510(k) 510(k) K163235
BP MDR Criteria Self-measurement Published evidence
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:

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

Relevant Publications:

Padwal RS. 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 Dec;22(6):379. doi: 10.1097/MBP.0000000000000295. PMID: 29112058.

The publication is a letter or correspondence in which the Omron HEM-9210T is referenced.

Alpert BS. Response to Regarding: validation of the Omron HEM-9210T by the ANSI/AAMI/ISO 81060-2 with two novel cuffs wide-range and extra-large Blood Press Monit. 2017 Dec;22(6):379-80. doi: 10.1097/MBP.0000000000000291. PMID: 29112059.

The publication is a letter or correspondence in which the Omron HEM-9210T is referenced.

Takahashi H. 欧州高血圧学会国際プロトコル(ESH-IP)改訂2010年版による家庭血圧監視装置Omron EVOLV(HEM-7600T-E),HEM-9210T,およびM3Comfort(HEM-7143-E)の妥当性確認. [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.] 日本臨床生理学会雑誌 [J Clin Physiol (Jpn)]. 2018 Feb 1;48(1):29-38. Retraction in: J Clin Physiol (Jpn). 2019 Feb 1;49(1):37-46.

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