Spirit CK-141
Device Model:
CK-141
Manufacturer:
Spirit Medical Co. Ltd., 2F - 68 Section 2, Guo Dao Road, Luzhon District, 24766 New Taipei City, TAIWAN ROC.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for professional use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Spirit CK-141 is a wall-mounted manually-operated aneroid sphygmomanometer. Blood pressure measurements are taken from the upper arm. It is intended for professional use.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Spirit CK-141 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.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None This is a manual device.
Device Family:
Guardian 51.10.000Z, Guardian 51.12.000Z, Guardian 51.14.000Z, Spirit CK-141Z, Spirit CK-142Z, Spirit CK-143Z
Legend: Z Almost Certain