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.
|Medaval||Legacy approval||Older clinical validation; older protocol|
|BIHS (UK and IRL)||Self-measurement||Published evidence|
|Stride BP||Self-measurement for adults||Published evidence|
|AMA VDL Criteria||Satisfies stated criteria||510(k) K061935 plus BHS:1993 validation|
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