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iHealth View (BP7S)

Device Name:View
Device Model:BP7S
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 self-measurement and home use
Measurement Site:Wrist
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the iHealth View (BP7S), 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
Stride BPSelf-measurement and professional use for adultsEquivalence claim without published evidence
 
Consumer BodyVersionQuartileComment
Consumer Reports (US)2019Fair 
Choice (Australia)2019B 

Device Family:Andon KD-723P, iHealth Sense BP7 (KD-972)B,P, iHealth View (BP7S)B,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 Sense BP7 (KD-972)

Wang Q, Zhao H, Chen W, Li N, Wan Y. Validation of the iHealth BP7 wrist blood pressure monitor, for self-measurement, according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2014 Feb;19(1):54-7. doi: 10.1097/MBP.0000000000000017. PMID: 24361919.

ESH-IP:2010 - Pass General population