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Fora Duo Ultima (D40a)

Device Name:Fora Duo Ultima
Device Model:D40a
Manufacturer:Puyang Technology Co. Ltd. (ForaCare), 1st Floor, 127 Wugong 2nd Road, Wugu District 24888, New Taipei City, TAIWAN PRC.
Measuring functions:Blood pressure, Blood glucose
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Description: The Fora Duo Ultima (D40a) is a non-clinically-validated automatic blood pressure monitor. Measurements are taken from the upper arm and 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 Duo Ultima (D40a) to measure blood pressure. 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 protocols compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNot recommendedThis device has not shown to have been clinically validated.

Device Family:Fora Duo Ultima (D40 Pro)Z, Fora Duo Ultima (D40a)Z, Fora Duo Ultima (D40b)Z, Fora Duo Ultima (D40d)Z, Fora Duo Ultima (D40g)Z (Z Almost Certain)