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

    Combo Electrotherapy Device

    K Number: K231440 · Decision Nov 3, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    7
    Review Days
    169

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    Basic Information

    Device Name
    Combo Electrotherapy Device
    K Number
    K231440
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Roundwhale Technology Co. , Ltd.
    Date Received
    May 18, 2023
    Decision Date
    November 3, 2023
    Product Code
    IPF
    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
    IPF Stimulator, Muscle, Powered

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    Other Clearances by Shenzhen Roundwhale Technology Co. , Ltd.

    K Number Device Name
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