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

    BASE ONLY, POWER WHEELCHAIR

    K Number: K832325 · Decision Aug 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    6
    Review Days
    28

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    Basic Information

    Device Name
    BASE ONLY, POWER WHEELCHAIR
    K Number
    K832325
    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
    July 15, 1983
    Decision Date
    August 12, 1983
    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
    K832321 ACCES. HEAD CONTROL-POWERED CHEELCHAIR
    K832322 BASE ONLY, TORONTO CHAIR
    K813104 POWER DRIVE WHEELCR
    K803307 MATTRESS, AIR FLOATATION, ALTERN. PRESS.