Joytech BSP-13

Device Model:

BSP-13

Manufacturer:

Brand: Zhejiang Joytech Healthcare Co. Ltd. (Former Name), 365 Wuzhou Road, Yuhang Economic Development Zone, Yuhang District, Hangzhou, Zhejiang 311100, CHINA.

Other: 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 Joytech BSP-13 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:

There appears to be no peer-reviewed clinical validation information available on the technology used in the Joytech BSP-13 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	Although equivalence to another device is claimed, this has not been tested to MDR requirements.

Device Family:

Fitage Fitage-06P, Joytech BSP-13Z, Sejoy Joytech DBP-1358P, Sejoy Joytech DBP-1333bP, Xuerui XR-BSP-13Z
Legend: P Stride Equivalence, 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.

Sejoy Joytech DBP-1333b

Hou G, Wu Y, Wang J, Zhi J. Validation of the DBP-1333b upper-arm blood pressure monitor according to the AAMI/ESH/ISO universal standard (ISO 81060-2:2018+Amd.1:2020). Blood Press Monit. 2024 Jun 1;29(3):149-155. Epub: 2024 Jan 9. doi: 10.1097/MBP.0000000000000688. PMID: 38193368.

81060-2:2020 - Pass General population