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510(k) Data Aggregation

    K Number
    K243136
    Device Name
    Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)
    Manufacturer
    Shenzhen Finicare Co., Ltd.
    Date Cleared
    2025-02-14

    (137 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Finicare Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Infrared Thermometer is a non-sterile, reusable, non-contact and handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
    Device Description
    The Non-contact Forehead Infrared Thermometer (Model FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) measures the body temperature based on the infrared energy emitted from the forehead. Users can get measurement results after properly scanning the forehead. The thermometer of a shell, an LCD, a measure button, a beeper, an infrared temperature sensor, and a Microprocessor. The device is widely used for home healthcare, medical institutes and many other occasions.
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    K Number
    K242721
    Device Name
    Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131)
    Manufacturer
    Shenzhen Finicare Co., Ltd.
    Date Cleared
    2024-10-04

    (24 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Finicare Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Upper Arm Electronic Blood Pressure Monitor, Models FC-BP103, FC-BP106,FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131 are intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The devices features include irreqular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected. The devices' feature includes Bluetooth function to transmit data to an external Bluetooth device with wireless communication.
    Device Description
    The subject device, Upper Arm Electronic Blood Pressure Monitor, is an automatic non-invasive blood pressure monitor which can be driven by 4 AA batteries or type-C USB (optional). It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy. The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor. The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2x120 sets of measurement values can be stored automatically. The earliest record will be deleted automatically to save the latest measurement value when more than the measurement values. The unit also calculates an average reading based on the values of the latest 3 times measurement. This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not. This blood pressure monitor has voice broadcast function. During measurement and recall the memory, there will be voice operation tips. The device detects an Irregular HeartBeat (IRB) (a Heartbeat that is more than 25% slower or 25% faster from the average Heartbeat) two or more times during the measurement, the irregular heartbeat Symbol will appear on the display with the measurement values. The device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device (FC-BP121 and FC-BP130 applied). There is a maximum pressure safety setting at 300 mmHg, when the pressure is more than 300mmHg, the device will exhaust fast automatically. No operation for 2 minute the device will shut down automatically. The device includes model FC-BP103, FC-BP106,FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131,they are same except the appearance.
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    K Number
    K231367
    Device Name
    Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)
    Manufacturer
    Shenzhen Finicare Co., Ltd.
    Date Cleared
    2023-09-18

    (130 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Finicare Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This blood pressure monitor (Model: FC-BP20), FC-BP201, FC-BP211, FC-BP220, FC-BP221) 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 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
    The subject device, Wrist Electronic Blood Pressure Monitor, is an automatic noninvasive blood pressure monitor which can be driven by AAA alkaline battery, DC3V. It uses an inflatable cuff which is wrapped around the patient's wrist to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy. The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor. The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2x120 sets of measurement values can be stored automatically. The unit also calculates an average reading based on the values of the latest 3 times measurement. This blood pressure monitor has the function of blood pressure classification according to WHO recommendation, which is convenient for you to judge whether your blood pressure is normal or not. This blood pressure monitor has voice broadcast function. During measurement and recall the memory, there will be voice operation tips. The device detects an Irregular Heart Beat (IHB) (a Heartbeat that is more than 25% slower or 25% faster from the average Heartbeat) two or more times during the measurement, the irregular heartbeat Symbol will appear on the display with the measurement values. The device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results through Bluetooth LE4.2 to paired Bluetooth-enabled device (FC-BP200, FC-BP210, FC-BP220 and FC-BP221 applied). There is a maximum pressure safety setting at 300 mmHg, when the pressure is more than 300mmHg, the device will exhaust fast automatically. No operation for 2 minute the device will shut down automatically. The device includes model FC-BP200, FC-BP201, FC-BP210, FC-BP211, FC-BP220, FC-BP221. Six models are identical in terms of software design, cuff type and measurement range. The schematic circuit diagram are identical in all models except for model FC-BP220. Six models PCB layout are different because of different appearance (such as structure, buttons layout, etc.) and function.
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    K Number
    K220113
    Device Name
    Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)
    Manufacturer
    Shenzhen Finicare Co., Ltd.
    Date Cleared
    2022-05-31

    (137 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Finicare Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Upper Arm Electronic Blood Pressure Monitor, Models FC-BP100,FC-BP102,FC-BP110,FC-BP111,FC-BP112 are intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected. The devices' feature includes Bluetooth function to transmit data to an external Bluetooth device with wireless communication.
    Device Description
    The subject device, Upper Arm Electronic Blood Pressure Monitor, is an automatic non-invasive blood pressure monitor which can be driven by 4 AA batteries or type-C USB (optional). It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy. The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor. The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2x90 sets of measurement values can be stored automatically. The earliest record will be deleted automatically to save the latest measurement value when more than 2x90 sets. The unit also calculates an average reading based on the values of the latest 3 times measurement. This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not. This blood pressure monitor has voice broadcast function. During measurement and recall the memory, there will be voice operation tips. The device detects an Irregular HeartBeat (IRB) (a Heartbeat that is more than 25% slower or 25% faster from the average Heartbeat) two or more times during the measurement, the irregular heartbeat Symbol will appear on the display with the measurement values. The device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device (FC-BP100 and FC-BP110 applied). There is a maximum pressure safety setting at 300 mmHq, when the pressure is more than 300mmHg, the device will exhaust fast automatically. No operation for 1 minute the device will shut down automatically. The device includes model FC-BP100.FC-BP101.FC-BP102.FC-BP110. FC-BP111. FC-BP112,they are same except the appearance.
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    K Number
    K181215
    Device Name
    Infrared Thermometer
    Manufacturer
    Shenzhen Finicare Co., Ltd.
    Date Cleared
    2019-01-02

    (240 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Finicare Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infrared Thermometer is intended for the measurement of human body temperatures. The forehead mode is indicated for people of all ages and the tympanic mode is indicated for people above three months old. The device can be used in the home setting and medical institutes.
    Device Description
    FC-IR series infrared thermometers (Models: FC-IR100, FC-IR101, FC-IR200, FC-IR300, FC-IR400) measure the body temperature through receiving infrared energy radiation via the ear or forehead. These thermometers have the capability to measure temperature via forehead temperature mode or ear temperature mode, and the temperature is directly shown on the LCD display. The device is intended to be used in the home setting and medical institutes. The product is mainly composed of infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display. It is powered by 2 X 1.5 AAA batteries. It focuses the infrared energy received from the human's forehead or ear by using the Fresnel lens of the thermometer. In addition, when measuring the ear temperature, the ear cover must be used by all thermometer models except for the FC-IR200. FC-IR101 model incorporates Bluetooth technology to wirelessly transmit temperature reading to an APP.
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