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iHealth Neo BP5S

Device Name:Neo BP5S
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 professional use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

While the technology used in the iHealth Neo BP5S, to measure blood pressure, has been declared as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but there is no evidence provided on a validation of the other device.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)Self-measurementManufacturer declaration of equivalence
ESH (Europe)Self-measurementThe BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.

Device Family:iHealth Feel BP5B, iHealth Neo BP5SB (B BIHS Derivative)
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)