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Fora Premium V10 (TD-4124)

Device Name:Fora Premium V10
Device Model:TD-4124
Manufacturer:ForaCare Inc., Suite D, 893 Patriot Drive, Moorpark, CA 93021, UNITED STATES.
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
Description: The Fora Premium V10 (TD-4124) is a clinically validated blood glucose meter. Measurements are normally taken from the finger but alternative site testing is allowed and it is intended for both professional use and self-measurement.
Assessment:

While the technology used in the Fora Premium V10 (TD-4124), to measure blood glucose, has been assessed, the results of the study have not been published and cannot be verified. It also appears to be very similar to another device by the same manufacturer but equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
Institute of Health Economics (CA)General useNo evidence provided

Device Family:Fora Premium V10 (TD-4124)Z, Fora Premium V10 BLE (TD-4124B)Z, Fora Premium V10a (TD-4124A)Z (Z Almost Certain)