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
Description:
The SensaCare SAA-102 is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
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.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | Legacy approval | Older clinical validation; older protocol |
| BP | BIHS (UK and IRL) | Self-measurement (Previous) | Published evidence |
| BP | ESH (Europe) | Self-measurement | Published evidence |
| BP | Stride BP | Self-measurement for adults | Published evidence |
| BP | FDA (US) | 510(k) | 510(k) K070086 |
Device Family:
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