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510(k) Data Aggregation

    K Number
    K240696
    Device Name
    Airdog X8 Air Purifier (KJ800F-X8)
    Manufacturer
    Suzhou Beiang Smart Technology Co., Ltd.
    Date Cleared
    2024-06-14

    (92 days)

    Product Code
    FRF
    Regulation Number
    880.5045
    Why did this record match?
    Applicant Name (Manufacturer) :

    Suzhou Beiang Smart Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Airdog X8 Air Purifier is a mobile air cleaner intended to remove particles from the air for medical purposes. The device is intended for indoor use only. The Airdog X8 has been demonstrated to effectively inactivate H3N2 and reduce Staphylococcus albus by 4 log with L5 speed.
    Device Description
    The Airdog X8 Air Purifier (X8) is a mobile air cleaner. The air from the room enters the X8 and passes a pre-filter, ionization frame, ionization field, collecting plates and carbon filter that captures particular matter and biological agents from the air. The X8 contains multiple PCB modules, device status indicators, power switch and a display panel, it allows user to select between different operation parameters, including auto-mode, sleep mode and wind speed. The Ionization wireframe and the collecting plate can be cleaned routinely and are reusable. X8 is powered from an AC wall outlet. It is intended to be used indoors only. The device is not intended to be connected to other instruments or medical devices.
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    K Number
    K230443
    Device Name
    TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
    Manufacturer
    Jiangxi Royall Smart Technology Co., Ltd.
    Date Cleared
    2023-05-22

    (90 days)

    Product Code
    NUH, NGX, NYN
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jiangxi Royall Smart Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04): - To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. - To stimulate healthy muscles in order to improve and facilitate muscle performance . - To temporarily increase local blood circulation in healthy muscles.
    Device Description
    TENS & EMS Device is a pain management device with a combination of TENS and EMS therapy technology. It can stimulate healthy muscles in order to improve and facilitate muscle performance, and temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. TENS & EMS Device (Model: LY-ET-01, LY-ET-04) has 3 modes (Model LY-ET-02 has 5 modes) and one channel, which provide electrical pulse stimulation through the electrode pads to the treatment area. The TENS & EMS Device has the operating elements of ON/OFF knob, Mode Selection button, Intensity adjustment Dial (or Intensity Increase button and Intensity decrease button) and Time Selection button which is user-friendly and easy to control. The device is equipped with electrode pads and electrode wire is used to connect the pads to the main unit. All the accessories can only be purchased by a local distributor.
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    K Number
    K203731
    Device Name
    DT100 Digital Thermometer
    Manufacturer
    Smart Technology Co., Ltd.
    Date Cleared
    2021-09-26

    (279 days)

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

    Smart Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DT100 Digital thermometer is intended for the measurement of human body temperature by doctor or consumers in the hospital or home. It can be used for axillary, oral and rectal measurement. The product is reusable and provided non-sterile. The device is for people of all ages.
    Device Description
    DT100 digital thermometer is a fast, highly accurate, and easy to use clinical instrument for measuring patient temperatures by oral, axillary or rectal means. The digital thermometer is a hand-held, reusable, multi-user, battery operated device. It has one model DT100.
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