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InBody BPBIO750

Device Model:BPBIO750
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:

While the technology used in the InBody BPBIO750, to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant 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)Public useManufacturer declaration of equivalence

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