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Fukuda Denshi FORM-5
Device Name:
Fukuda Denshi Co. Ltd., 2-23-5 Kita Ueno, Taito-Ku, Tokyo 110-0014, JAPAN.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for professional use
Measurement Site:
Arm and Ankle
Measurement Occurrence:
Single measurements only
Available Currently
Availability according to Countries or Regions:
The Fukuda Denshi FORM-5 is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Measurements are taken from the upper arm and ankle. It is intended for professional use.
While the technology used in the Fukuda Denshi FORM-5, to measure blood pressure, has been declared as being equivalent to that used in another device, not only has no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4, but there is no evidence provided on a validation of the other device.
Accuracy AssessmentRecommendationBasis
BP Medaval None While a clinical validation is claimed, it cannot be checked properly.
BP Japanese Society of Hypertension Professional use (2021-2022) Equivalence claim without published evidence
Device Family:
Fukuda Denshi FORM-5J, Fukuda Denshi SC-1800 (COL-SC-1800)J, Fukuda Denshi DS-1200J
Legend: J JHS Implied Equivalence