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AViTA BPM64 (v2)
Device Model:
BPM64
Manufacturer:
AViTA Corporation, 9F No. 78 Sec 1, Gwang-Fu Road, Sanchong Dist., New Taipei City 24158, TAIWAN ROC.
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
Description:
The AViTA BPM64 (v2) is an automatic blood pressure monitor. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the AViTA BPM64 (v2) to measure blood pressure.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval Not recommended This device has not been clinically validated.
BP Stride BP Self-measurement for adults (Preferred) Published evidence, but the device validated was the .
Device Family:
AViTA BPM64 (v1)P, AViTA BPM64 (v2)P, AViTA BPM68P, AViTA BPM82P, AViTA BPM83P, Novama First+ (V2)P, Novama Prime (BPM83)Z, Novama Prime+ (BPM83)P, Novama White M (BPM82)Z, Novama White M+ (BPM82)Z
Legend: P Stride Equivalence, Z Almost Certain
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.

AViTA BPM64 (v1)

Kang YY, Chen Q, Liu CY, Li Y, Wang JG. Validation of the AVITA BPM64 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2018 Feb;23(1):45-8. Epub: 2017 Oct 18. doi: 10.1097/MBP.0000000000000296. PMID: 29049094.

ESH-IP:2010 - Pass General population

AViTA BPM82

Menti A, Ntousopoulos V, Theodosiadi A, Stathopoulou P, Kollias A, Stergiou GS. Validation of the automated oscillometric upper-arm cuff home blood pressure monitor AVITA BPM82 in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard. Blood Press Monit. 2024 Apr 1;29(2):89-92. Epub: 2023 Nov 6. doi: 10.1097/MBP.0000000000000682. PMID: 37937605.

81060-2:2020 - Pass General population

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