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

    SONICSTIMU COMBO THERAPEUTIC DEVICE

    K Number: K120217 · Decision Nov 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    54
    Applicant Total
    25
    Review Days
    302

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    Basic Information

    Device Name
    SONICSTIMU COMBO THERAPEUTIC DEVICE
    K Number
    K120217
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shenzhen Dongdixin Technology Co., Ltd.
    Date Received
    January 24, 2012
    Decision Date
    November 21, 2012
    Product Code
    IMG
    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
    IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

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