BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    EMS (FlexPulse, MagnaCore, Magnetika)

    K Number: K241601 · Decision Feb 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    161
    Applicant Total
    2
    Review Days
    266

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    Basic Information

    Device Name
    EMS (FlexPulse, MagnaCore, Magnetika)
    K Number
    K241601
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cpmt Laser (Canadian Pioneer Medical Technology Corporation)
    Date Received
    June 4, 2024
    Decision Date
    February 25, 2025
    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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    Other Clearances by Cpmt Laser (Canadian Pioneer Medical Technology Corporation)

    K Number Device Name
    K232133 Co2 Laser System, Models: PureLase And VanLase