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

    POWER DRIVE WHEELCR

    K Number: K813104 · Decision Nov 20, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    6
    Review Days
    17

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    Basic Information

    Device Name
    POWER DRIVE WHEELCR
    K Number
    K813104
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Intl. Medical Equipment Corp.
    Date Received
    November 3, 1981
    Decision Date
    November 20, 1981
    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 Intl. Medical Equipment Corp.

    K Number Device Name
    K832745 OC3 FLYER
    K832325 BASE ONLY, POWER WHEELCHAIR
    K832321 ACCES. HEAD CONTROL-POWERED CHEELCHAIR
    K832322 BASE ONLY, TORONTO CHAIR
    K803307 MATTRESS, AIR FLOATATION, ALTERN. PRESS.