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    FDA 510(k) FDA class 2 Substantially Equivalent 🇪🇸 Spain

    I-Motion

    K Number: K212413 · Decision May 26, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    161
    Applicant Total
    1
    Review Days
    296

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    Basic Information

    Device Name
    I-Motion
    K Number
    K212413
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    I-Motion Group Global Iberica S.L.
    Date Received
    August 3, 2021
    Decision Date
    May 26, 2022
    Product Code
    NGX
    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
    NGX Stimulator, Muscle, Powered, For Muscle Conditioning

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