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510(k) Data Aggregation

    K Number
    K240333
    Device Name
    Wearable Digital Thermometer (T31)
    Manufacturer
    Guangdong Genial Technology CO., Ltd.
    Date Cleared
    2024-10-30

    (268 days)

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

    Guangdong Genial Technology CO., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wearable Digital Thermometer is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. Wearable Digital Thermometer is reusable and intended for armpit temperature monitoring for persons of all age. The temperature data of device is not intended to replace the advice, diagnosis, nor treatment recommendations of doctor. Wearable Digital Thermometer can be used at home and healthcare center.
    Device Description
    The Wearable Digital Thermometer consists of a host, App software and stickers. A comprehensive Android and iOS App are provided to access the host from a smart device. It is used for measuring and monitoring armpit temperature in real-time continuously and remotely via Bluetooth to smart device. The medical double-sided sticker are used to fix and stick the host in the user`s axilla. The NTC temperature sensor is located closely to the stainless steel sheet that make sure the accuracy of temperature data measured. The subject device could measure and monitor temperature in real-time continuously and remotely via Bluetooth to smart phone. The Temp Pal is the combination device of thermometer and Bluetooth communication unit intended to be worn at axilla to monitor the armpit temperature continuously. The subject device is a direct mode clinical thermometer where the output temperature is not adjusted. For the monitoring operation, switch the thermometer on and stick the thermometer in the user's axilla. The thermometer will make a Bluetooth connection between the thermometer and the receiver automatically (User should setup Bluetooth properly on receiver). Then the thermometer starts to measure the body temperature. The wireless thermometer uses a rechargeable battery for operation. When the battery is low, internal circuit will detect the low battery condition automatically and send "low battery" signal through Bluetooth communication unit to receiver.
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    K Number
    K232678
    Device Name
    Digital Thermometer, Model T28, T28L
    Manufacturer
    Guangdong Genial Technology Co., Ltd.
    Date Cleared
    2024-01-31

    (152 days)

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

    Guangdong Genial Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The digital thermometer is intended for the measurement and monitoring of human body temperature through or axillary as the measurement site on people of all ages by doctor or user in the hospital or home.
    Device Description
    Digital Thermometer, Model T28, T28L
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    K Number
    K231250
    Device Name
    Digital Blood Pressure Monitor
    Manufacturer
    Guangdong Genial Technology Co., Ltd.
    Date Cleared
    2023-11-28

    (211 days)

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

    Guangdong Genial Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Digital Blood Pressure Monitor is intended to measure (systolic and diastolic) and pulse rate of adults.
    Device Description
    Not Found
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    K Number
    K231245
    Device Name
    Digital Blood Pressure Monitor (Arm Type)
    Manufacturer
    Guangdong Genial Technology Co., Ltd.
    Date Cleared
    2023-11-22

    (205 days)

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

    Guangdong Genial Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The devices are intended to measure the systolic blood pressure, and pulse rate of an adult more than 12 years old individual by using a non-invasive technique, in which an inflatable cuff (220mm ~ 320mm) is wrapped around the arm. It can be used in medical facilities or at home. It is supplied for OTC use.
    Device Description
    Digital Blood Pressure Monitor (Arm Type)
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    K Number
    K231243
    Device Name
    Finger Clip Pulse Oximeter
    Manufacturer
    Guangdong Genial Technology Co., Ltd.
    Date Cleared
    2023-10-31

    (183 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangdong Genial Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Finger Clip Pulse Oximeter is a handheld non-invasive and multi-use device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate in hospital-type facilities, and homecare. This device is not recommended for use during exercise or low perfusion scenarios. This device is not intended for use on infants and newborns. (Recommended for people over 3 years and the thickness of finger greater than or equal to 7mm).
    Device Description
    Not Found
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