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iHealth Clear (BPM1)

Device Name:Clear (BPM1)
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:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Description: The iHealth Clear (BPM1) is a clinically validated automatic blood pressure monitor. Measurements are taken from the upper arm and it is intended for self-measurement and home use.
Assessment:

The technology used in the iHealth Clear (BPM1), 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.
Stride BPSelf-measurement and professional use for adults (Preferred)Equivalence claim without published evidence
 
Consumer BodyYear(s)LevelComment
Consumer Reports (US)2018-2021Very Good 

Device Family:iHealth BP3 (KD-931)P, iHealth Clear (BPM1)P (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 BP3 (KD-931)

Chen C, Shang F, Wang J, Chen J, Ji N, Wan Y. Validation of the iHealth BP3 upper-arm blood pressure monitor, for clinic use and self-measurement, according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2012 Dec;17(6):253-6. doi: 10.1097/MBP.0b013e32835b9ecb. PMID: 23147535.

ESH-IP:2010 - Pass General population