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Sejoy Joytech DBP-1314 (Sejoy BP-103H)

Device Model:DBP-1314, BP-103H
Manufacturer:

Brand: Sejoy Electronics & Instruments Co. Ltd. (Former Name and Address), Building 2, 202 Zhenzhong Road, West Lake Economy & Technology Zone, Hangzhou 310030, CHINA.

Sole: 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-1314 (Sejoy BP-103H) is a non-clinically-validated automatic blood pressure monitor. Measurements are taken from the upper arm and 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 Sejoy Joytech DBP-1314 (Sejoy BP-103H) to measure blood pressure. However, this device appears to be very similar to another device by the same (OEM) manufacturer. At least one validation needs to be published and equivalence needs to be proven according to protocols compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNot recommendedThis device has not shown to have been clinically validated.

Device Family:Aspen BP-103HZ, Healthcare World BP-103HZ, HyMark DBP-1314 (BP-103H)Z, LotFancy BP-103HZ, Sejoy BP-103Z, Sejoy Joytech DBP-1314 (Sejoy BP-103H)Z (Z Almost Certain)