BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    THERMAL MASSAGE BED, MODEL 2D-GX

    K Number: K102281 · Decision Dec 22, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    65
    Applicant Total
    2
    Review Days
    133

    Basic Information

    Device Name
    THERMAL MASSAGE BED, MODEL 2D-GX
    K Number
    K102281
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.5880
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    INAREX CORPORATION
    Date Received
    August 11, 2010
    Decision Date
    December 22, 2010
    Product Code
    JFB
    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
    JFB Table, Physical Therapy, Multi Function

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    Other Clearances by INAREX CORPORATION

    K Number Device Name
    K080554 INAREX, MODEL 2D-LX