Accoson Freestyle Desk (AC0012)


Device Name:
Freestyle Desk/Table
Device Model:
AC0012
Manufacturer:
Accoson Ltd., Grieg House, Block 1, Annickbank Campus, Annick Road, Irvine, Ayrshire KA11 4LF, UNITED KINGDOM.
Measuring functions:
Blood Pressure and PR
Primary Client Use:
Intended for professional use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Discontinued but still available
Description:
The Accoson Freestyle Desk (AC0012) is a desk (tabletop) manually-operated mercury sphygmomanometer. Blood pressure measurements are taken from the upper arm. It is intended for professional use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Accoson Freestyle Desk (AC0012) to measure blood pressure. However, this device appears to be very similar to another device by the same manufacturer or a device within a family of equivalent devices. At least one validation needs to be published and equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
Accuracy Assessment | Recommendation | Basis | |
BP | Medaval | None | This is a manual device. |
Device Family:
Accoson Freestyle Desk (AC0012)Z, Accoson Freestyle Stand (AC0042)Z, Accoson Freestyle Wall (AC0022)Z
Legend: Z Almost Certain
Legend: Z Almost Certain