BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MOMENTUM NO. FS008 WHEELCHAIR

    K Number: K982099 · Decision Oct 5, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    445
    Applicant Total
    1
    Review Days
    112

    Basic Information

    Device Name
    MOMENTUM NO. FS008 WHEELCHAIR
    K Number
    K982099
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    SRIRAM ENTERPRISES D.B.A. MOMENTUM GROUP
    Date Received
    June 15, 1998
    Decision Date
    October 5, 1998
    Product Code
    IOR
    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
    IOR Wheelchair, Mechanical

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