Nissei DSK-1011
Device Model:
DSK-1011
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
Availability according to Countries or Regions:
Japan
Device Manual:
Device Specifications:
Description:
The Nissei DSK-1011 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:
The technology used in the Nissei DSK-1011, 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.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | While a clinical validation is claimed, it cannot be checked properly. |
| BP | Japanese Society of Hypertension | Self-measurement (Latest: 2016-2022) | No evidence provided |
Device Family:
Nissei DSK-1011D, Nissei WSK-1021D, Nissei WSK-1021JZ, Nissei DSK-1011JZ
Legend: D DET Equivalence, Z Almost Certain
Legend: D DET Equivalence, Z Almost Certain