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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RT

    K Number: K070489 · Decision Mar 14, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    23
    Review Days
    22

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    Basic Information

    Device Name
    HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RT
    K Number
    K070489
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Heartway Medical Products Co., Ltd.
    Date Received
    February 20, 2007
    Decision Date
    March 14, 2007
    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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