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

    SOLAX

    K Number: K131302 · Decision Nov 26, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    11
    Review Days
    203

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    Basic Information

    Device Name
    SOLAX
    K Number
    K131302
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dongguan Prestige Sporting Goods Co., Ltd.
    Date Received
    May 7, 2013
    Decision Date
    November 26, 2013
    Product Code
    INI
    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
    INI Vehicle, Motorized 3-Wheeled

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    Other Clearances by Dongguan Prestige Sporting Goods Co., Ltd.

    K Number Device Name
    K190737 Solax Electric Scooter (Models: S204311M, S204161, S204143)
    K192190 Solax Electric Scooter
    K200978 Electric Wheelchair (Model: S7110)
    K202632 Electric wheelchair (S7204/S7205)
    K201508 Infrared Thermometer
    K202549 Solax Electric Scooter (Model: S202261B)
    K191897 Solax Electric Scooter (Models: S3023, S3024, S3025, S3026)
    K200857 Electric wheelchair (Model: S7012)
    K182400 Solax Powered Wheelchair (Models: S7101, S7103)
    K182576 Solax Powered Wheelchair
    Search all 11 clearances from Dongguan Prestige Sporting Goods Co., Ltd. →