BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    KARMA-RS, KARMA-FS WHEELCHAIRS

    K Number: K884812 · Decision Dec 27, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    7
    Review Days
    40

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    Basic Information

    Device Name
    KARMA-RS, KARMA-FS WHEELCHAIRS
    K Number
    K884812
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Orthofab, Inc.
    Date Received
    November 17, 1988
    Decision Date
    December 27, 1988
    Product Code
    ITI
    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
    ITI Wheelchair, Powered

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