Handok Barozen HBP570

Device Model:

HBP570

Manufacturer:

OBL: Handok Inc., Handok Tower, 132 Teheran-ro, Gangnam-gu, Seoul 06235, REPUBLIC of KOREA.

OEM: 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 professional use

Measurement Site:

Upper Arm

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Description:

The Handok Barozen HBP570 is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for professional use.

Assessment:

The technology used in the Handok Barozen HBP570, 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.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	Stride BP	Office use for adults (Preferred)	Equivalence claim without published evidence

Device Family:

Handok Barozen HBP570P, InBody BPBIO250P
Legend: 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 BPBIO250

Kollias A, Gravvani A, Anagnostopoulos I, Kyriakoulis KG, Bountzona I, Menti A, Stergiou GS. Validation of the InBody BPBIO250 oscillometric blood pressure monitor for professional office use in 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. 2020 Apr;25(2):115-117. Epub: 2020 Jan 4. doi: 10.1097/MBP.0000000000000428. PMID: 31913149.

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