InBody BPBIO220

Description:

The InBody BPBIO220 is a desk (tabletop) manually-operated mercury-free sphygmomanometer. Blood pressure measurements are taken from the upper arm. It is intended for professional use.

Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the InBody BPBIO220 to measure blood pressure. However, this device appears to be very similar to a validated device by the same (OEM) manufacturer or a device within a family of equivalent devices, but equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	This is a manual device. Equivalence to a validated device is possible but this has not been tested to MDR requirements.
BP	AMA VDL (US)	Office use	Manufacturer declaration of equivalence

Device Family:

InBody BPBIO210Z, InBody BPBIO220Z
Legend: 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 BPBIO210

Ntineri A, Menti A, Kyriakoulis KG, Bountzona I, Prapa S, Kollias A, Stergiou GS. Validation of the InBody BPBIO210 manual auscultatory hybrid device for professional office use in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard. Blood Press Monit. 2022 Apr 1;27(2):135-138. Epub: 2021 Oct 11. doi: 10.1097/MBP.0000000000000571. PMID: 34636810.

81060-2:2019 - Pass General population (Note: Medium (22 cm to 32 cm) and Large (32 cm to 42 cm) cuffs tested)