Nihon Seimitsu Sokki Co. Ltd. (Nissei), 2508-13 Nakago Shibukawa, Gunma 377-0293, JAPAN.
Primary Client Use:
Intended for self-measurement and home use
Single measurements only
Availability according to Countries or Regions:
The Nissei DSK-1031 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 upper arm. It is intended for self-measurement and home use.
The technology used in the Nissei DSK-1031, to measure blood pressure, has been compared to a clinically validated device, but not according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
|While a clinical validation is claimed, it cannot be checked properly.
|Japanese Society of Hypertension
|No evidence provided