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Avita BPM636
Device Model:
BPM636
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:
Discontinued but still available
Availability according to Countries or Regions:
United States
Device Manual:
Description:
The Avita BPM636 is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
The technology used in the Avita BPM636, to measure blood pressure, has passed in two clinical validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval ★★ Recommendation Recent clinical validation; older protocol; multiple clinical validations
BP AMA VDL (US) Self-measurement Equivalence claim without published evidence
Validation Publications:

Lee CN, Wu CK, Huang IC. Validation of the AViTA BPM636 upper arm blood pressure monitor in adults and pregnant women according to the ANSI/AAMI/ISO 81060-2:2013. Blood Press Monit. 2023 Aug 1;28(4):215-220. Epub: 2023 Apr 5. doi: 10.1097/MBP.0000000000000648. PMID: 37074406. Available from: PMC10309106.

81060-2:2013 - Pass (n=85)

81060-2:2013 - Pass Pregnancy (n=46)