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 Assessment	Recommendation	Basis
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