Fora Premium Voice V12 (TD-4125)
Device Name:
Fora Premium Voice
Device Model:
V12, TD-4125
Manufacturer:
ForaCare Inc., Suite D, 893 Patriot Drive, Moorpark, CA 93021, UNITED STATES.
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
Device Accessibility:
Voiced instructions and results
Availability:
Available Currently
Availability according to Countries or Regions:
United States
Device Manual:
Description:
The Fora Premium Voice V12 (TD-4125) is an automatic blood glucose meter. Medaval has not found evidence proving the accuracy of its blood glucose measurement technology. 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 Premium Voice V12 (TD-4125) to measure blood glucose. However, this device appears to be very similar to another device by the same manufacturer. 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 | |
| BG | Medaval | Not recommended | This device has not been shown to have been clinically validated. |
Device Family: