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510(k) Data Aggregation

    K Number
    K250425
    Device Name
    Ultraviolet Phototherapy Device
    Manufacturer
    APK Technology Co., Ltd.
    Date Cleared
    2025-04-07

    (52 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    APK Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ultraviolet Phototherapy Device is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leukoderma on all skin types (I-VI).
    Device Description
    Ultraviolet Phototherapy Device
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    K Number
    K172981
    Device Name
    Reusable SpO2 Sensors, Disposable SpO2 Sensors
    Manufacturer
    APK Technology Co., Ltd.
    Date Cleared
    2018-06-08

    (254 days)

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

    APK Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The devices are intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive oximeter equipment. The sensors are reusable depending on models, and are intended for adult, pediatric or infant, depending on models. They shall be used in healthcare settings.
    Device Description
    The proposed device, SpO2 Sensors are accessories to the oximeters, which are intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in noninvasive U.S. legally marketed oximeters or patient monitors. The sensors are reusable or disposable depending on models, and are intended for adult, pediatric or infant, depending on models. The proposed devices measure, along with the corresponding oximeters, non-invasively, the arterial oxygen saturation of blood. The measurement method is based on the red and infrared light absorption of hemoglobin and oxyhemoglobin. Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. The light is emitted through human finger and received by a photodiode. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb). The patient contact components include cable and sensor. The contact level is surface device and contact duration is limited contact (less than 24h).
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    K Number
    K170536
    Device Name
    ECG Disposable Lead Wire
    Manufacturer
    APK Technology Co., Ltd.
    Date Cleared
    2017-04-24

    (60 days)

    Product Code
    DSA
    Regulation Number
    870.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    APK Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ECG Disposable Lead Wires are intended to be used with ECG. The lead wire is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.
    Device Description
    The ECG Disposable Lead Wires are comprised of patient end termination, leadwire and patient leadwire connector. The device is used to transmit ECG signals from electrodes which are affixed to the patient's body for both diagnostic and monitoring purposes. Each lead wire is attached to ECG patient electrodes. The lead wire connector plugs into one end of the external trunk cable which are plug into an ECG monitor.
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