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

    CHIPS POWERED WHEELCHAIR

    K Number: K955548 · Decision Sep 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    2
    Review Days
    290

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    Basic Information

    Device Name
    CHIPS POWERED WHEELCHAIR
    K Number
    K955548
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    International Healthcare Solutions, Inc.
    Date Received
    December 5, 1995
    Decision Date
    September 20, 1996
    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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    Other Clearances by International Healthcare Solutions, Inc.

    K Number Device Name
    K955547 CHIPS STANDUP WHEELCHAIR