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

    Power Wheelchair (W5915B, W5915C, W5915D)

    K Number: K253812 · Decision Jun 18, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    18
    Review Days
    202

    Basic Information

    Device Name
    Power Wheelchair (W5915B, W5915C, W5915D)
    K Number
    K253812
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    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
    June 18, 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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    Other Clearances by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

    K Number Device Name
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    K240008 Mobility Scooter (W3331)
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    K230964 Power Wheelchair (N5909)
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