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

    Mobility Scooter

    K Number: K240990 · Decision Sep 10, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    346
    Applicant Total
    18
    Review Days
    152

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    Basic Information

    Device Name
    Mobility Scooter
    K Number
    K240990
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3800
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
    Date Received
    April 11, 2024
    Decision Date
    September 10, 2024
    Product Code
    INI
    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
    INI Vehicle, Motorized 3-Wheeled

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    Other Clearances by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

    K Number Device Name
    K253812 Power Wheelchair (W5915B, W5915C, W5915D)
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    K253806 Power Wheelchair (N5919 series)
    K242471 Power Wheelchair (W5538)
    K242387 Mobility Scooter (N3473)
    K240008 Mobility Scooter (W3331)
    K240012 Mobility Scooter (W3431)
    K230964 Power Wheelchair (N5909)
    K231508 Power Wheelchair, W5521
    K231428 Mobility Scooter (Models: W3431D)
    Search all 18 clearances from Zhejiang Innuovo Rehabilitation Devices Co.,Ltd →