BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Electric Wheelchair (Model: S7110)

    K Number: K200978 · Decision Apr 16, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    11
    Review Days
    368

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    Basic Information

    Device Name
    Electric Wheelchair (Model: S7110)
    K Number
    K200978
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dongguan Prestige Sporting Goods Co., Ltd.
    Date Received
    April 13, 2020
    Decision Date
    April 16, 2021
    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 Dongguan Prestige Sporting Goods Co., Ltd.

    K Number Device Name
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    K202632 Electric wheelchair (S7204/S7205)
    K201508 Infrared Thermometer
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    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
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    Search all 11 clearances from Dongguan Prestige Sporting Goods Co., Ltd. →