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InBody BPBIO320N

Device Model:BPBIO320N
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
Description: The InBody BPBIO320N is a clinically validated automatic blood pressure monitor. Measurements are taken from the upper arm and it is intended for use as a public facility.
Assessment:

The technology used in the InBody BPBIO320N, 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 BPPublic use for adults (Preferred)Equivalence claim without published evidence

Device Family:InBody BPBIO320B,P, InBody BPBIO320NP, InBody BPBIO320SP, InBody BPBIO330P, InBody BPBIO330NP, InBody BPBIO750B,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.

InBody BPBIO320

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

InBody BPBIO320S

Moon JH, Kang MK, Choi CE, Min J, Lee HY, Lim S. Validation of a wearable cuff-less wristwatch-type blood pressure monitoring device. Sci Rep. 2020 Nov 4;10(1):19015. doi: 10.1038/s41598-020-75892-y. PMID: 33149118. Available from: PMC7642418.

Ad Hoc protocol General population

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. 2021 Apr 1;26(2):146-148. Epub: 2020 Dec 14. doi: 10.1097/MBP.0000000000000507. PMID: 33323723.

81060-2:2019 - Pass General population