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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 a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

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)