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Citizen CH-550

Device Model:CH-550
Manufacturer:Citizen Systems Japan Co. Ltd., 6-1-12 Tanashi-cho, Nishi-Tokyo-Shi, Tokyo 188-8511, 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
Assessment:

The technology used in the Citizen CH-550, to measure blood pressure, has been compared to a clinically validated device but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
Japanese Society of HypertensionSelf-measurement (2016-2018)Unpublished equivalence to Citizen CH-432B, by questionnaire

Device Family:Citizen CH-432J, Citizen CH-432BD, Citizen CH-452D,J, Citizen CH-453FJ, Citizen CH-550J, Citizen CHU-302J, Citizen CHU-501J, Citizen CHU-502J (D DET Equivalence, J JHS Implied Equivalence)
Validation Publications for Equivalent Devices

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Citizen CH-432B

Cotte UV, Faltenbacher VH, von Willich W, Bogner JR. Trial of validation of two devices for self-measurement of blood pressure according to the European Society of Hypertension International Protocol: the Citizen CH-432B and the Citizen CH-656C. Blood Press Monit. 2008 Feb;13(1):55-62. doi: 10.1097/MBP.0b013e3282cb599a. PMID: 18199925. Erratum in: Blood Press Monit. 2008 Aug;13(4):243.

ESH-IP:2002 - Pass General population