BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

    ShockPhysio Mobile (model SW3200 Basic)

    K Number: K240358 · Decision Jun 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    759
    Registration Numbers
    759
    Same Product Code
    99
    Applicant Total
    25
    Review Days
    120

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    Basic Information

    Device Name
    ShockPhysio Mobile (model SW3200 Basic)
    K Number
    K240358
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5660
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shenzhen Dongdixin Technology Co., Ltd.
    Date Received
    February 6, 2024
    Decision Date
    June 5, 2024
    Product Code
    ISA
    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
    ISA Massager, Therapeutic, Electric

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