Fora D20 No-Coding
Device Name:
Fora No-Coding
Device Model:
D20
Manufacturer:
ForaCare Inc., Suite D, 893 Patriot Drive, Moorpark, CA 93021, UNITED STATES.
Measuring functions:
Blood Pressure, Blood glucose and PR
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
BP: Upper Arm; BG: Finger and general Alternative Site Testing
Measurement Occurrence:
BP & BG: Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
United States
Device Manual:
Description:
The Fora D20 No-Coding is a dual monitor for blood pressure and blood glucose. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology and the accuracy of its blood glucose measurement technology has yet to be proven to mdr requirements. Blood pressure measurements are taken from the upper arm and blood glucose measurements are normally taken from the finger but alternative site testing is allowed. It is intended for self-measurement and home use.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Fora D20 No-Coding to measure blood pressure. While the technology used in the Fora D20 No-Coding, to measure blood glucose, has been assessed, the results of the study have not been published and cannot be verified.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | Not recommended | This device has not been clinically validated. |