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HealthWorks SCLV-2007 Cardio-Vascular Lab

Device Name:SCLV-2007 Cardio-Vascular Lab
Manufacturer:HealthWorks France (MedActive), 6 rue de Castellanne, Paris 75008, FRANCE.
Measuring functions:Blood pressure
Primary Client Use:Intended for professional use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only

While the technology used in the HealthWorks SCLV-2007 Cardio-Vascular Lab, to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, 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.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)Professional useManufacturer declaration of equivalence

Device Family:HealthWorks SCLV-2007 Cardio-Vascular LabB, K-jump KP-7770D, Spengler KP7500 DB,D, Spengler TB-101B (B BIHS Derivative, D DET 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.

Spengler KP7500 D

Belghazi J, El Feghali RN, Moussalem T, Rejdych M, Asmar RG. Validation of four automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension. Vasc Health Risk Manag. 2007;3(4):389-400. PMID: 17969368. Available from: PMC2291343.

ESH-IP:2002 - Pass General population