iHealth Track (KN-550BT)

Device Name:Track
Device Model:KN-550BT
Manufacturer:

OBL: iHealthlabs Europe SAS, 36 Rue de Ponthieu, 75008 Paris, FRANCE.

OEM: Andon Health Co. Ltd., 3 Jinping Road, Ya'an Street, Nankai District, Tianjin 300190, CHINA.

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 iHealth Track (KN-550BT), to measure blood pressure, has been compared to a validated device but the results of the 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.