Citizen CHUH7191
Device Model:
CHUH7191
Manufacturer:
Citizen Systems Japan Co. Ltd., 6-1-12 Tanashi-cho, Nishi-Tokyo-Shi, Tokyo 188-8511, JAPAN.
Measuring functions:
Blood Pressure and PR
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Citizen CHUH7191 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:
While the technology used in the Citizen CHUH7191, 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.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None While a clinical validation is claimed, it cannot be checked properly.
BP Japanese Society of Hypertension Self-measurement (2025) Implied equivalence to the Citizen CHUH533 CHUH719 or CHUH904C
Device Family:
Citizen CHUH5331J, Citizen CHUH7191J, Citizen CHUH9041CJ
Legend: J JHS Implied Equivalence