BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    True Non-Surgical Spinal Decompression System (DRX9000-SL)

    K Number: K243775 · Decision Jul 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    70
    Applicant Total
    2
    Review Days
    221

    Basic Information

    Device Name
    True Non-Surgical Spinal Decompression System (DRX9000-SL)
    K Number
    K243775
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5900
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Excite Medical of Tampa Bay, LLC
    Date Received
    December 9, 2024
    Decision Date
    July 18, 2025
    Product Code
    ITH
    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
    ITH Equipment, Traction, Powered

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