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

    HEARTWAY POWER WHEELCHAIR

    K Number: K132856 · Decision Jul 15, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    23
    Review Days
    306

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    Basic Information

    Device Name
    HEARTWAY POWER WHEELCHAIR
    K Number
    K132856
    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
    September 12, 2013
    Decision Date
    July 15, 2014
    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 Heartway Medical Products Co., Ltd.

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    K132855 HEARTWAY POWER MOBILITY SCOOTER
    K101143 HEARTWAY POWER MOBILITY SCOOTER, S11
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