Fora Comfort Basic (G20, TD-4251)
Device Name:
Fora Fora Comfort Basic
Device Model:
G20, TD-4251
Manufacturer:
ForaCare Suisse AG, Neugasse 55, CH-9000 St. Gallen, SWITZERLAND.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger and general Alternative Site Testing
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
United Arab Emirates, Switzerland and United States
Device Manual:
Description:
The Fora Comfort Basic (G20, TD-4251) 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 self-measurement and home use.
Assessment:
While the technology used in the Fora Comfort Basic (G20, TD-4251), 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 | Institute of Health Economics (CA) | General use | No evidence provided |