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510(k) Data Aggregation

    K Number
    K992120
    Device Name
    DYNAWELL OR DYNAWELL
    Manufacturer
    EKEROTH QUALITY AB
    Date Cleared
    1999-08-13

    (51 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    EKEROTH QUALITY AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Accessory for axial compression of the Lumbar spine in CT and MR Indication For Use. "Accessory for was vempresses during research and clinical purposes.
    Device Description
    Through compression of the spine with a Harness, two cords and a foot part improve CT and MR diagnostic of the spinal canal.
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