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Maisense Freescan BPM-490

Device Name:Freescan
Device Model:BPM-490
Manufacturer:Maisense Inc., 12F-8, 100 Sec. 1, Jiafeng 11th Rd., Zhubei City, Hsinchu County 30273, TAIWAN PRC.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Radial Artery
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the Maisense Freescan BPM-490, 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.

Accuracy AssessmentRecommendationBasis
Medaval★★ RecommendationRecent clinical validation; recent protocol
MDR CriteriaSelf-measurementPublished evidence

Validation Publications

Boubouchairopoulou N, Kollias A, Chiu B, Chen B, Lagou S, Anestis P, Stergiou GS. A novel cuffless device for self-measurement of blood pressure: concept, performance and clinical validation. J Hum Hypertens. 2017 Jul;31(7):479-82. Epub: 2017 Jan 26. doi: 10.1038/jhh.2016.101. PMID: 28124684.

81060-2:2013 - Pass General population