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

    POWERED INFLATABLE TUBE MASSAGER, SPORT-MED

    K Number: K901022 · Decision Mar 14, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    152
    Applicant Total
    4
    Review Days
    9

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    Basic Information

    Device Name
    POWERED INFLATABLE TUBE MASSAGER, SPORT-MED
    K Number
    K901022
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Damor America, Inc.
    Date Received
    March 5, 1990
    Decision Date
    March 14, 1990
    Product Code
    IRP
    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
    IRP Massager, Powered Inflatable Tube

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    Other Clearances by Damor America, Inc.

    K Number Device Name
    K934267 DAMOR CREAM SATURATED DRESSING
    K933328 DAMOR CREME
    K891097 DAMOR CREAM SATURATED DRESSING