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:

Accuracy AssessmentRecommendationBasis
MedavalRecommended for pregnancy onlyValidation in pregnancy
BIHS (UK and IRL)Self-measurementManufacturer declaration of equivalence
ESH (Europe)Self-measurementThe BIHS recommendation, despite the absence of scientific evidence according to the same authors' criteria.

Validation Publications

Van Den Heuvel JFM, Lely AT, Franx A, Bekker MN. Validation of the iHealth Track and Omron HEM-9210T automated blood pressure devices for use in pregnancy. Pregnancy Hypertens. 2019 Jan. 37-41 p. doi: 10.1016/j.preghy.2018.10.008. PMID: 30825925.

ESH-IP:2010 - Pass Pregnancy (n=33) including pre-eclampsia (n=10)

Relevant Publications

Mazoteras-Pardo V, Becerro-De-Bengoa-Vallejo R, Losa-Iglesias ME, López-López D, Palomo-López P, Rodríguez-Sanz D, Calvo-Lobo C. Validation in the General Population of the iHealth Track Blood Pressure Monitor for Self-Measurement According to the European Society of Hypertension International Protocol Revision 2010: Descriptive Investigation. JMIR Mhealth Uhealth. 2019 Mar 19;7(3):e13137. doi: 10.2196/13137. PMID: 30888331. Available from: PMC6444211.

The reference device used was the Omron M3 Intellisense (HEM-7051-E). However, this is a major and fundamental violation of the protocol requirements. Despite its claims, this study is simply a comparison of two devices and cannot be considered as a validation according to the ESH-IP protocol.