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

    Electric wheelchair (S7204/S7205)

    K Number: K202632 · Decision Apr 8, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    11
    Review Days
    209

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    Basic Information

    Device Name
    Electric wheelchair (S7204/S7205)
    K Number
    K202632
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dongguan Prestige Sporting Goods Co., Ltd.
    Date Received
    September 11, 2020
    Decision Date
    April 8, 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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    K200978 Electric Wheelchair (Model: S7110)
    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
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    Search all 11 clearances from Dongguan Prestige Sporting Goods Co., Ltd. →