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

    Electrically powered wheelchair (KZ301B)

    K Number: K252494 · Decision Dec 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    2
    Review Days
    119

    Basic Information

    Device Name
    Electrically powered wheelchair (KZ301B)
    K Number
    K252494
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanjing Kangni Smart Technology Co., Ltd.
    Date Received
    August 8, 2025
    Decision Date
    December 5, 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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