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

    TIPOWER POWERDRIVE AND RIMPOWER X & SX

    K Number: K020539 · Decision Jun 20, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    550
    Applicant Total
    5
    Review Days
    121

    Basic Information

    Device Name
    TIPOWER POWERDRIVE AND RIMPOWER X & SX
    K Number
    K020539
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    TISPORT
    Date Received
    February 19, 2002
    Decision Date
    June 20, 2002
    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 TISPORT

    K Number Device Name
    K023606 TILITE YG AND TILITE YGS
    K020639 TIPOWER TR RIMPOWER AND TIPOWER TRA RIMPOWER
    K990555 TISPORT X AND TISPORT XC
    K990358 CROSS SPORT, RIGID WHEELCHAIR