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

    Electric wheelchair (JJW-7002, JJW-7003)

    K Number: K253849 · Decision Mar 20, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    2
    Review Days
    108

    Basic Information

    Device Name
    Electric wheelchair (JJW-7002, JJW-7003)
    K Number
    K253849
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ZheJiang J&J Mobility Co., Ltd.
    Date Received
    December 2, 2025
    Decision Date
    March 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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