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Fora Premium V10a (TD-4124A)
Device Name:
Fora Premium V10a
Device Model:
TD-4124A
Manufacturer:

OBL: ForaCare Inc., Suite D, 893 Patriot Drive, Moorpark, CA 93021, UNITED STATES.

OEM: TaiDoc Technology Corporation, 6F - 127 Wugong 2nd Road, 24888 Wugu District, New Taipei City, TAIWAN ROC.

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 V10a (TD-4124A) 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 Premium V10a (TD-4124A), 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.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BG Institute of Health Economics (CA) General use No evidence provided
Device Family:
Fora Premium V10 (TD-4124)Z, Fora Premium V10a (TD-4124A)Z, Fora Premium V10 BLE (TD-4124B)Z
Legend: Z Almost Certain