iHealth Ease (BP3L)

Description:

The iHealth Ease (BP3L) is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.

Assessment:

The technology used in the iHealth Ease (BP3L), 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.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	Stride BP	Self-measurement and professional use for adults (Preferred)	Equivalence claim without published evidence

	Consumer Body	Year(s)	Level	Comment
BP	Choice (Australia)	Previous	B

Device Family:

iHealth Feel BP5B,P, iHealth Ease (BP3L)P, iHealth Neo BP5SB,P
Legend: B BIHS Derivative, P Stride 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.

iHealth Feel BP5

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)