Fora Diamond Voice (DM20)
Device Name:
Fora Diamond Voice
Device Model:
DM20
Manufacturer:
Puyang Technology Co. Ltd. (ForaCare), 1st Floor, 127 Wugong 2nd Road, Wugu District 24888, New Taipei City, TAIWAN ROC.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for both professional use and self-measurement
Measurement Site:
Finger and general Alternative Site Testing
Measurement Occurrence:
Single measurements only
Device Accessibility:
Voiced instructions and results
Availability:
Available Currently
Availability according to Countries or Regions:
United Arab Emirates and Switzerland
Description:
The Fora Diamond Voice (DM20) is an automatic blood glucose meter. The accuracy of its blood glucose measurement technology has yet to be proven to MDR requirements. Blood glucose measurements are normally taken from the finger but alternative site testing is allowed. It is intended for both professional use and self-measurement.
Assessment:
While the technology used in the Fora Diamond Voice (DM20), 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 | |
| BG | Medaval | None | While a clinical validation is claimed, it cannot be checked properly. |
| BG | TÜV SÜD (DE) | General use | Unpublished internal data |