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

    Electric Wheelchair (F309)

    K Number: K250758 · Decision May 9, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    1
    Review Days
    57

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    Basic Information

    Device Name
    Electric Wheelchair (F309)
    K Number
    K250758
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Changshu Pingfang Wheelchair Co., Ltd.
    Date Received
    March 13, 2025
    Decision Date
    May 9, 2025
    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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