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Fora V30 (TD-4242)
Device Name:
Fora V30
Device Model:
TD-4242
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 V30 (TD-4242) 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 V30 (TD-4242), to measure blood glucose, has been assessed, the results of the study have not been published and cannot be verified.
Recommendations:
Accuracy AssessmentRecommendationBasis
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