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

    Power Wheelchair (N5919 series)

    K Number: K253806 · Decision Apr 20, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    18
    Review Days
    143

    Basic Information

    Device Name
    Power Wheelchair (N5919 series)
    K Number
    K253806
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
    Date Received
    November 28, 2025
    Decision Date
    April 20, 2026
    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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