The Nissei WSK-1021J is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.

There appears to be no peer-reviewed clinical validation information available on the technology used in the Nissei WSK-1021J to measure blood pressure. However, this device appears to be very similar to another device by the same manufacturer or a device within a family of equivalent devices. At least one validation needs to be published and equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	While a clinical validation is claimed, it cannot be checked properly.