Omron Heartguide BP8000-M (HEM-6410T-ZM)
Device Name:
Heartguide BP8000-M
Device Model:
HEM-6410T-ZM
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:
Wrist
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
United States
Description:
The Omron Heartguide BP8000-M (HEM-6410T-ZM) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 1-star Medaval rating. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.
Assessment:
The technology used in the Omron Heartguide BP8000-M (HEM-6410T-ZM), to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval ★ Recommendation Recent clinical validation; older protocol
BP Stride BP Self-measurement for adults (Unavailable) Published evidence
BP AMA VDL (US) Self-measurement Published evidence plus 510(k) K182481
BP FDA (US) 510(k) 510(k) K182481
BP MDR Criteria Self-measurement Published evidence
Device Family:
Omron HEM-6131F, Omron BP652N (HEM-6300-Z)F, Omron HeartGuide (HEM-6411T-MAE)P, Omron Heartguide BP8000-M (HEM-6410T-ZM)P,F, Omron BP4350 (HEM-6232T-Z) GoldF, Omron BP6100 (HEM-6180-Z)F
Legend: P Stride Equivalence, F FDA 510(k)
Validation Publications:

Kuwabara M, Harada K, Hishiki Y, Kario K. Validation of two watch-type wearable blood pressure monitors according to the ANSI/AAMI/ISO81060-2:2013 guidelines: Omron HEM-6410T-ZM and HEM-6410T-ZL. J Clin Hypertens (Greenwich). 2019 Jun;21(6):853-858. Epub: 2019 Feb 25. doi: 10.1111/jch.13499. PMID: 30803128.

81060-2:2013 - Pass General population

Relevant Publications:

Kario K, Shimbo D, Tomitani N, Kanegae H, Schwartz JE, Williams B. The first study comparing a wearable watch-type blood pressure monitor with a conventional ambulatory blood pressure monitor on in-office and out-of-office settings. J Clin Hypertens (Greenwich). 2020 Feb;22(2):135-141. Epub: 2020 Jan 19. doi: 10.1111/jch.13799. PMID: 31955505.

Measurements from the Omron Heartguide BP8000-M (HEM-6410T-ZM) are compared to those from the A&D TM-2441, though not in a formal validation.

Liang Z, Chapa-Martell MA. Validation of Omron Wearable Blood Pressure Monitor HeartGuide™ in Free-Living Environments. In: Wireless Mobile Communication and Healthcare: 9th International Conference, MobiHealth 2020, Virtual Event, November 19, 2020, Proceedings. Eds: Ye J, O'Grady MJ, Civitarese G, Yordanova K. Basel, Switzerland: Springer Nature; 2021 Mar 24. p. 339-350.

Measurements from the Omron Heartguide BP8000-M (HEM-6410T-ZM) are compared to those from the Omron HEM-1022, though not in a formal validation.

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