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Omron HeartGuide (HEM-6411T-MAE)

Device Name:HeartGuide
Device Model:HEM-6411T-MAE
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:Wrist
Measurement Occurrence:Continuous measurement
Availability:Available Currently
Description: The Omron HeartGuide (HEM-6411T-MAE) is a clinically validated automatic blood pressure monitor. Measurements are taken from the wrist and it is intended for self-measurement and home use.

The technology used in the Omron HeartGuide (HEM-6411T-MAE), to measure blood pressure, has been compared to a clinically validated device but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
Stride BPSelf-measurement for adultsEquivalence claim without published evidence

Device Family:Omron BP4350 (HEM-6232T-Z) GoldF, Omron BP6100 (HEM-6180-Z)F, Omron BP652N (HEM-6300-Z)F, Omron HeartGuide (HEM-6411T-MAE)P, Omron Heartguide BP8000-M (HEM-6410T-ZM)P,F, Omron HEM-6131F (P Stride Equivalence, 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 Heartguide BP8000-M (HEM-6410T-ZM)

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