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510(k) Data Aggregation
K Number
K182018Device Name
Bluetooth blood pressure monitor
Manufacturer
Date Cleared
2018-10-06
(71 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Kingyield Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This blood pressure monitor is intended to be used to measure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a symbol with reading. The device is intended for using in only adult population, not applied to the other populations such as neonatal baby. It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The wrist circumference is limited to 13.5cm - 21.5cm.
Device Description
Bluetooth Blood Pressure Monitor, BPW1 is a fully automatic non-invasive blood pressure monitor which measures systolic and diastolic blood pressure and heart rate of adult population using the oscillometric method, including irregular heartbeats (IHB) from the wrist. The device is powered by a rechargeable Lithium battery. The device has an START/STOP button for starting the measurement and stopping the measurement at any time when measuring. The MEM button is for displaying the last measurement. The device can also connect the mobile platform with an MMA (mobile medical application) as its accessory which can start/stop the device through Bluetooth 4.0. An irregular heartbeats rhythm is defined as a rhythm that varies by 25% less or more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure.
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K Number
K161530Device Name
Bluetooth blood pressure monitor
Manufacturer
Date Cleared
2017-03-31
(302 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BW-BW1 Bluetooth Blood Pressure Monitor is intended to measure blood pressure (systolic and diastolic) and heart rate from the wrist using the oscillometric method, the measured data is transferred to a smart phone for the patient record archiving and/or measured data analysis purpose.
The device is intended for use in only adult population, not applied to the other populations such as neonatal baby.
It can not be used while the wrist (arm) has bleeding or wound the blood flowing from the wound in pressurizing.
Device Description
Not Found
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K Number
K123801Device Name
FINGER PULSE OXIMETER
Manufacturer
Date Cleared
2013-05-28
(169 days)
Product Code
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PM601 Finger pulse oximeter is intended for spot-checking oxygen saturation in blood (SpO2) and pulse rate. The pulse oximeter is used on adults at hospital, clinics, and/or home. Not for continuously monitoring.
Device Description
The proposed device, Finger Pulse Oximeters PM601 is a fingertip device, which can display % SpO2. pulse rate value and pulse strength. It is based on digital blood oxygen. Power consumption of the proposed device is low and the two originally-equipped AAA alkaline batteries can be operated continuously for 24 hours. It will automatically turned off when no signal is detected for more than 8 seconds. And low voltage warning will be displayed and battery symbol flash when battery voltage is low.
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K Number
K112042Device Name
KINGYIELD WRIST BLOOD PRESSURE MONITOR
Manufacturer
Date Cleared
2012-02-10
(207 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BP210 Wrist Blood Pressure Monitor is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method.
The device is intended for using in only adult population, not applied to the other populations such as neonatal baby.
It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.
The cuff circumference is limited to 13.5cm - 21.5cm.
Device Description
BP210 Wrist Blood Pressure Monitor is designed to measure systolic and diastolic blood pressure, pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method is a well - known technique in the market called the "oscillometric method".
The device stores automatically 180 (2*90) sets of measurement values with the measuring date and time. You can read the stored data conveniently by pressing the memory button. If any irregular heartbeat is detected, the symbol IHB will be displayed on the LCD. Moreover, it has the function of averaging the last three measurement values. The memory data can be transferred to the PC by connecting the device with the PC via USB cable.
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K Number
K083043Device Name
KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201
Manufacturer
Date Cleared
2008-10-27
(13 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
It can be used as medical assistant instrument at home or in medical center for adult population for measuring systolic and diastolic blood pressure and heart rate.
The device is intended for use in only adult population, not applied to the other populations such as neonatal baby.
It can not be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.
Device Description
BP201 Wrist Blood Pressure Monitor is a fully automatic non-invasive blood pressure monitor which measures systolic and diastolic blood pressure and heart rate of adult population using the oscillometric method by inflating an inflatable cuff on the wrist.
BP201 Wrist Blood Pressure Monitor uses an inflated cuff which is wrapped around the wrist .The cuff is inflated by a built-in air pump. The systolic and diastolic blood pressures are determined by Oscillometric method. The inflation rate is controlled by MCU at a constant rate 2~5mmHg/second. The user can release the cuff to stop measuring by pressing the "START/STOP" button at any time while measuring. The measuring result is displayed in LCD.
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