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510(k) Data Aggregation
K Number
K241634Device Name
Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)
Date Cleared
2025-02-11
(250 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Guangdong Xinyu Electronic and Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Wrist Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home. The intended wrist circumference is 13.5-21.5 cm.
Device Description
The Wrist Blood Pressure Monitor, including XY-W01B, can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person with wrist circumference of 135-215mm through oscillometric method. The initial inflation pressure of the cuff is zero pressure. When start the cuff will be inflated and deflated. The Wrist Blood Pressure Monitor is composed of monitor unit and wrist cuff. Of which the monitor unit contains main control circuit board, air pump, deflation valve, LCD and shell. The two models XY-W01A and XY-W01B have the same intended use, working principle, measuring range, accuracy, cuff, and conformance standard, except for product appearance. The devices are powered by 2 AAA batteries. The Wrist Blood Pressure Monitor has a memory function that automatically stores 90 sets data of the latest measurements.
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K Number
K241590Device Name
Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)
Date Cleared
2025-02-03
(245 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Guangdong Xinyu Electronic and Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.
Device Description
The Arm Blood Pressure Monitor, including XY-B01, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09, can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person with arm circumference of 220-320mm through oscillometric method. The initial inflation pressure of the cuff is zero pressure. When start the device, the cuff will be inflated and deflated. The Arm Blood Pressure Monitor is composed of monitor unit and arm cuff. Of which, the main unit contains main control circuit board, air pump, deflation valve, LCD and shell. The seven models have the same intended use, working principle, measuring range, cuff, and conformance standard, except for appearance and power supply. The devices are powered by 4*AA batteries (XY-B02) or 4*AAA batteries (other models). The Arm Blood Pressure Monitor has a memory function that automatically stores 2*60 sets data of the latest measurements.
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