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HealthSTATS BPro

Device Name:BPro
Device Model:T6200
Manufacturer:HealthSTATS International Pte Ltd., 3 Ang Mo Kio Street, 62 08-25/26, 569139 Singapore, SINGAPORE.
Measuring functions:Blood pressure
Primary Client Use:Intended for ambulatory blood pressure monitoring
Measurement Site:Wrist
Measurement Occurrence:Continuous measurement
Availability:Available Currently
Assessment:

The technology used in the HealthSTATS BPro, 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
MedavalLegacy approvalOlder clinical validation; older protocol
BIHS (UK and IRL)ABPMPublished evidence
AMA VDL CriteriaSatisfies stated criteria510(k) K060315 plus SP10:2002 validation

Validation Publications

Nair D, Tan SY, Gan HW, Lim SF, Tan J, Zhu M, Gao H, Chua NH, Peh WL, Mak KH. The use of ambulatory tonometric radial arterial wave capture to measure ambulatory blood pressure: the validation of a novel wrist-bound device in adults. J Hum Hypertens. 2008 Mar;22(3):220-2. Epub: 2007 Nov 8. doi: 10.1038/sj.jhh.1002306. PMID: 17992251. Available from: www.nature.com. Reseach Letter.

ESH-IP:2002 - Pass General population (Note: Insufficient detail provided to support result)

Relevant Publications

Komori T, Eguchi K, Hoshide S, Williams B, Kario K. Comparison of wrist-type and arm-type 24-h blood pressure monitoring devices for ambulatory use. Blood Press Monit. 2013 Feb;18(1):57-62. doi: 10.1097/MBP.0b013e32835d124f. PMID: 23263536.

Measurements from the HealthSTATS BPro are compared to those from the A&D TM-2431, though not in a formal validation.