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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
Description: The iHealth Neo BP5S is a clinically validated automatic blood pressure monitor. Measurements are taken from the upper arm and it is intended for professional use.
Assessment:

The technology used in the iHealth Neo BP5S, 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.

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.
Stride BPSelf-measurement and professional use for adults (Preferred)Equivalence claim without published evidence

Device Family:iHealth Ease (BP3L)P, iHealth Feel BP5B,P, iHealth Neo BP5SB,P (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)