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LotFancy BP-103H

Device Model:BP-103H
Manufacturer:

Brand: LotFancy, ℅ Ding Heping, 1113 Lane, 2729 Road, Hunan, Shanghai, CHINA.

OBL: LotFancy Inc., Suite D, 330 Shaw Road, South San Francisco, CA 94080, UNITED STATES.

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 LotFancy 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 LotFancy 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.