Nissei DSK-1031J
![](/images/devices/Nissei/DSK-1031J.jpg)
Device Model:
DSK-1031J
Manufacturer:
Nihon Seimitsu Sokki Co. Ltd. (Nissei), 2508-13 Nakago Shibukawa, Gunma 377-0293, JAPAN.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Nissei DSK-1031J 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.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Nissei DSK-1031J 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 a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
Accuracy Assessment | Recommendation | Basis | |
BP | Medaval | None | While a clinical validation is claimed, it cannot be checked properly. |
Device Family:
Nissei DSK-1031D, Nissei DSK-1051D, Nissei DSK-1031JZ, Nissei DSK-1051JZ
Legend: D DET Equivalence, Z Almost Certain
Legend: D DET Equivalence, Z Almost Certain