BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    V12 PRO

    K Number: K210913 · Decision Aug 4, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    152
    Applicant Total
    2
    Review Days
    128

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    Basic Information

    Device Name
    V12 PRO
    K Number
    K210913
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Slk Medical GmbH
    Date Received
    March 29, 2021
    Decision Date
    August 4, 2021
    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 Slk Medical GmbH

    K Number Device Name
    K193476 VariLymph 12 pro