Sejoy BSP-12
Device Model:
BSP-12
Manufacturer:
Brand: Sejoy Electronics & Instruments Co. Ltd. (Former Name and Address), Building 2, 202 Zhenzhong Road, West Lake Economy & Technology Zone, Hangzhou 310030, 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:
Discontinued but still available
Description:
The Sejoy BSP-12 is an automatic blood pressure monitor. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Sejoy BSP-12 to measure blood pressure. However, this device appears to be very similar to another device by the same (OEM) manufacturer or a device within a family of equivalent devices. At least one validation needs to be published and 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 | Not recommended | This device has not been shown to have been clinically validated. |
Device Family: