Sejoy Joytech DBP-6282B
Device Model:
DBP-6282B
Manufacturer:
OBL: Hangjhou Sejoy Electronics & Instrument Co. Ltd. Joytech Healthcare Co. Ltd., Area C Building 2, 365 Wuzhou Road, Yuhang Economic Development Zone, Yuhang District, Hangzhou City, Zhejiang 311100, CHINA.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Sejoy Joytech DBP-6282B 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 Sejoy Joytech DBP-6282B, 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 (Preferred) | Equivalence to the Joytech DBP-6279B claim without published evidence |
Device Family:
Sejoy Joytech DBP-6279BP, Sejoy Joytech DBP-6191HDP, Sejoy Joytech DBP-6282BP, Sejoy Joytech DBP-6285BP
Legend: P Stride Equivalence
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