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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Compression Therapy Device Model LGT-2200SP

    K Number: K191862 · Decision Oct 29, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    152
    Applicant Total
    6
    Review Days
    110

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    Basic Information

    Device Name
    Compression Therapy Device Model LGT-2200SP
    K Number
    K191862
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangzhou Longest Science & Technology Co., Ltd.
    Date Received
    July 11, 2019
    Decision Date
    October 29, 2019
    Product Code
    IRP
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IRP Massager, Powered Inflatable Tube

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    Other Clearances by Guangzhou Longest Science & Technology Co., Ltd.

    K Number Device Name
    K202110 MStim Drop Model: LGT-233
    K201845 Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)
    K182020 Portable Electro-Stimulation Therapy Device
    K191856 Compression Therapy Device
    K182108 Portable Electro-Stimulation Therapy Device