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

    T-2000-POWER TILT SEATING SYSTEM, MODELS ARD-TSTORM, ARD-TP-320, ARD-TG424, ARD-TS525, ARD-TJAZZY, ARD-TLANCER

    K Number: K992804 · Decision Feb 3, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    4
    Review Days
    168

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    Basic Information

    Device Name
    T-2000-POWER TILT SEATING SYSTEM, MODELS ARD-TSTORM, ARD-TP-320, ARD-TG424, ARD-TS525, ARD-TJAZZY, ARD-TLANCER
    K Number
    K992804
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Accelerated Rehab Designs, Inc.
    Date Received
    August 19, 1999
    Decision Date
    February 3, 2000
    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 Accelerated Rehab Designs, Inc.

    K Number Device Name
    K012281 TRS-2000 POWER TILT/POWER RECLINE SYSTEM
    K010011 TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM
    K992828 E-2000 POWER ELEVATING SEAT SYSTEM, MODELS ARD-ESTORM, ARD-EP320, ARD-ELANCER