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SensaCare SAW-102

Device Model:SAW-102
Manufacturer:Sensacare Ltd., 11/F AXA Centre, 151 Gloucester Rd., Wanchai, HONG KONG PRC.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Wrist
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the SensaCare SAW-102, 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; older protocol
BIHS (UK and IRL)Self-measurementPublished evidence
AMA VDL CriteriaGeneral use510(k) K061935 plus BHS:1993 validation

Device Family:Medel ReplayD (D DET Equivalence)
Validation Publications

Zaetta V, Longo D, Perkovic D, Perfetti P, Gabrieli A, Pratticò F, Winnicki M. Validation of the SAW-102 wrist home blood pressure monitor according to the protocols of the British Hypertension Society, the Association for the Advancement of Medical Instrumentation, and the European Society of Hypertension. Blood Press Monit. 2009 Feb;14(1):32-6. doi: 10.1097/MBP.0b013e3283105496. PMID: 19262198.

ESH-IP:2002 - Pass General population

BHS:1993 - Pass (B/B) General population

SP10:1996 - Pass General population