Device Model:
XR-BP-2116
Manufacturer:
OBL: Shanghai Xuerui Import & Export Co. Ltd., Room 06 - 10/F Block B, SilvaBay Tower, 269 Haining Road, 200080 Shanghai, CHINA.
OEM: 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:
Wrist
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Xuerui XR-BP-2116 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 wrist. 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 Xuerui XR-BP-2116 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:
LotFancy BP-2208Z,
Sejoy BP-202Z,
Sejoy Joytech DBP-2116 (Sejoy BP-2116)F,
Sejoy Joytech DBP-2208 (Sejoy BP-2208)F,
Sejoy Joytech DBP-2220 (V1) (Sejoy BP-2220, Joytech DBP-2220)F,
Sejoy Joytech DBP-2141 (Sejoy BSP-21)F,
Sejoy Joytech DBP-2242 (Sejoy BSP-22)F,
Sejoy Joytech DBP-2127F,
Sejoy Joytech DBP-2152F,
Sejoy Joytech DBP-2156F,
Sejoy Joytech DBP-2202F,
Sejoy Joytech DBP-2228F,
Sejoy Joytech DBP-2229F,
Sejoy Joytech DBP-2206 (Sejoy BP-2206)F,
Sejoy Joytech DBP-2253F,
Sejoy Joytech DBP-2101F,
Sejoy Joytech DBP-2220 (V2)Z,
Xuerui XR-BP-202Z,
Xuerui XR-BP-2116Z,
Xuerui XR-BP-2206Z,
Xuerui XR-BP-2208 (v1)Z,
Xuerui XR-BP-2220ZLegend:
F FDA 510(k),
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-2242 (Sejoy BSP-22)
Jin Y, Bei X, Jin Y. Validation of the validity of the new wrist-type fully automatic blood pressure monitor: DBP-2242 according to ISO 81060-2:2018+AMD 1:2020. Blood Press Monit. Epub: 2024 Jul 16. doi: 10.1097/MBP.0000000000000716. PMID: 39008685.
81060-2:2020 - Pass General population
