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510(k) Data Aggregation

    K Number
    K963704
    Device Name
    MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE
    Manufacturer
    SHIPPERT MEDICAL TECHNOLOGIES CORP.
    Date Cleared
    1996-11-26

    (71 days)

    Product Code
    LYG
    Regulation Number
    890.5660
    Why did this record match?
    Product Code :

    LYG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used in the treatment and management of muscle spasm and muscle tension.
    Device Description
    The proposed changes to an already approved and marketed device does in no way alter the safety and effectiveness of this medical device. The modifications of design change of "S" shape, adding roller beads and handles, adding interchangeable massage balls and adding a collapsible feature does not change the safety or effectiveness of this device.
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    K Number
    K936312
    Device Name
    MANUAL MASSAGE ROLLER
    Manufacturer
    MCKENNA & CUNEO
    Date Cleared
    1996-01-29

    (794 days)

    Product Code
    LYG
    Regulation Number
    890.5660
    Why did this record match?
    Product Code :

    LYG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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