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.
|Medaval||Legacy approval||Older clinical validation; older protocol|
|BIHS (UK and IRL)||Self-measurement||Published evidence|
|ESH (Europe)||Self-measurement||Published evidence|
|Stride BP||Self-measurement for adults||Published evidence|
|AMA VDL Criteria||Satisfies stated criteria||510(k) K070086 plus BHS:1993 validation|
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