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SensaCare SAA-102

Device Model:SAA-102
Manufacturer:SensaCare Ltd., Unit 803, 9 Wing Hong Street, Cheung Sha Wan, Kowloon, HONG KONG PRC.
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
Assessment:

The technology used in the SensaCare SAA-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
MedavalLegacy approvalOlder clinical validation; older protocol
BIHS (UK and IRL)Self-measurementPublished evidence
ESH (Europe)Self-measurementPublished evidence
Stride BPSelf-measurement for adultsPublished evidence
AMA VDL CriteriaSatisfies stated criteria510(k) K070086 plus BHS:1993 validation

Device Family:Medel Idea (91913)D, SensaCare SAA-102D (D DET Equivalence)
Validation Publications

Zaetta V, Daniele L, Perkovic D, Pratticò F, Barisa M, Perfetti P, Gabrieli A, Buonocore F, Winnicki M. Validation of the SAA-102 home blood pressure monitor according to the protocols of the European Society of Hypertension, the Association for the Advancement of Medical Instrumentation and the British Society of Hypertension. Blood Press Monit. 2007 Dec;12(6):363-8. PMID: 18004104.

ESH-IP:2002 - Pass General population

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

SP10:1996 - Pass General population