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

    SIDEKICK POWER WHEELCHAIR

    K Number: K954044 · Decision Oct 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    3
    Review Days
    45

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    Basic Information

    Device Name
    SIDEKICK POWER WHEELCHAIR
    K Number
    K954044
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    21st Century Scientific, Inc.
    Date Received
    August 29, 1995
    Decision Date
    October 13, 1995
    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 21st Century Scientific, Inc.

    K Number Device Name
    K193599 BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair
    K901210 BOUNDER VA POWER WHEELCHAIR