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.
|BP||Medaval||★★★★★ Certified Accuracy||Recent clinical validation; recent protocol with certified adherence; multiple clinical validations|
|BP||BIHS (UK and IRL)||Self-measurement||Published evidence|
|BP||ESH (Europe)||Self-measurement||Published evidence|
|BP||Stride BP||Self-measurement for adults (Preferred)||Published evidence|
|BP||Consumer Reports (US)||Latest: 2018-2021||Very Good|
Legend: B BIHS Derivative, P Stride Equivalence
Shang F, Zhu Y, Zhu Z, Liu L, Wan Y. Validation of the iHealth BP5 wireless upper arm blood pressure monitor for self-measurement according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2013 Oct;18(5):278-81. doi: 10.1097/MBP.0b013e3283638f04. PMID: 23797053.
ESH-IP:2010 - Pass General population
Hofstede A, Wollaars H, van Drongelen J. A clinical evaluation of blood pressure measurement by iHealth BP5 in pregnancy. Pregnancy Hypertens. 2019 Jul;17:69-74. Epub: 2019 May 9. doi: 10.1016/j.preghy.2019.05.011. PMID: 31487660.
ESH-IP:2010 - Pass (n=45)
Medaval Certification Assessment
Medaval Ltd. Accreditation assessment of the blood pressure measurement technology used in the iHealth Feel (BP5) upper arm monitor, as validated according to the European Society of Hypertension International Protocol revision 2010. Medical Device Assessment. 2016 Aug 5;2016(1602) 5 p. Epub: 2019 Jan 31. Available from: www.medaval.ie.
With proven validity of validation results according to an accepted protocol, the clinical accuracy of the blood pressure measurement technology, used in the iHealth Feel BP5, is certified by Medaval Ltd.