Aposán DBP-6194

Description:

The Aposán DBP-6194 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 self-measurement and home use.

Assessment:

The technology used in the Aposán DBP-6194, 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	Self-measurement for adults	Equivalence to the Sejoy Joytech DBP-6279B claim without published evidence

Device Family:

Aposán DBP-6194P, Sejoy Joytech DBP-6191P, Sejoy Joytech DBP-6192P, Sejoy Joytech DBP-6279BP, Sejoy Joytech DBP-6191HDP, Sejoy Joytech DBP-6282BP, Sejoy Joytech DBP-6285BP
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.

Sejoy Joytech DBP-6279B

Duan B, He L, Zhang J, Fang L, Li G. Validation of the JOYTECH DBP-6279B blood pressure monitor in adults and adolescents according to the AAMI/ESH/ISO universal standard(ISO 81060-2:2018 + Amd.1:2020). Blood Press Monit. 2023 Oct 1;28(5):284-288. Epub: 2023 Jul 12. doi: 10.1097/MBP.0000000000000662. PMID: 37434533. Available from: PMC10484188.

81060-2:2020 - Pass General population