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iHealth BP3 (KD-931)
Device Name:
BP3
Device Model:
KD-931
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
Device Manual:
Description:
The iHealth BP3 (KD-931) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a certified 4-star Medaval rating. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
The accuracy of the technology used in the iHealth BP3 (KD-931), to measure blood pressure, is certified by Medaval Ltd. It has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval
BP BIHS (UK and IRL) Self-measurement Published evidence
BP ESH (Europe) Self-measurement Published evidence
BP Stride BP Self-measurement and professional use for adults (Preferred) Published evidence
Device Family:
iHealth BP3 (KD-931)P, iHealth Clear (BPM1)P
Legend: P Stride Equivalence
Validation Publications:

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

Medaval Certification Assessment

Certification ImageMedaval Ltd. Accreditation assessment of the blood pressure measurement technology used in the iHealth BP3 upper arm monitor, as validated according to the European Society of Hypertension International Protocol revision 2010. Medical Device Assessment. 2016 Aug 5;2016(1601) 5 p. Epub: 2019 Jan 30. Available from: www.medaval.ie.

With proven validity of validation results according to an accepted protocol, the clinical accuracy of the blood pressure measurement technology, used in the iHealth BP3 (KD-931), is certified by Medaval Ltd.