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InBody BPBIO320

Device Model:BPBIO320
Manufacturer:Sole: InBody Co. Ltd., InBody Building, 54 Nonhyeon-ro 2-gil, Gangnam-gu, Seoul 06313, REPUBLIC of KOREA.
Measuring functions:Blood pressure
Primary Client Use:Intended for use as a public facility
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the InBody BPBIO320, to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Accuracy AssessmentRecommendationBasis
Medaval★★ RecommendationRecent clinical validation; recent protocol
BIHS (UK and IRL)Public usePublished evidence
Stride BPPublic use for adults (Preferred)Published evidence

Device Family:InBody BPBIO320B, InBody BPBIO320NZ, InBody BPBIO750B (B BIHS Derivative, Z Almost Certain)
Validation Publications

Kollias A, Stambolliu E, Kyriakoulis KG, Papadatos SS, Stergiou GS. Validation of the single-cuff oscillometric blood pressure monitor InBody BPBIO320 for public use according to the 2010 European Society of Hypertension International Protocol. Blood Press Monit. 2019 Feb;24(1):30-32. Epub: 2018 Dec 7. doi: 10.1097/MBP.0000000000000359. PMID: 30531495.

ESH-IP:2010 - Pass General population

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.

InBody BPBIO750

Ntineri A, Prapa S, Bountzona I, Menti A, Stergiou GS. Validation of the single-cuff oscillometric blood pressure monitor InBody BPBIO750 for public spaces according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard. Blood Press Monit. Epub: 2020 Dec 14. doi: 10.1097/MBP.0000000000000507. PMID: 33323723.

81060-2:2018 - Pass General population