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510(k) Data Aggregation

    K Number
    K083044
    Device Name
    HUBANG, MODEL HBL13/HBG12-S
    Manufacturer
    SHANGHAI HUBANG MEDICAL APPLIANCES CO., LTD.
    Date Cleared
    2008-12-12

    (59 days)

    Product Code
    IOR,89I
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K012370
    Why did this record match?
    Device Name :

    HUBANG, MODEL HBL13/HBG12-S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor or indoor.

    Device Description

    They consist of a rigid, mechanical, steel(HBG12-S)/aluminum(HBL13) frame and nylon upholstery back and seat. They have two 24" rear wheels and two 8" front casters for turning and maneuverability.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for manual wheelchairs and does not contain information about an AI device or its performance criteria, studies, or associated details like sample sizes, ground truth establishment, or expert involvement. Therefore, I cannot extract the requested information to fill in the table and answer the questions.

    The document is a 510(k) summary for the "HUBANG HBL13/HBG12-S manual wheelchair" submitted by Shanghai Hubang Medical Appliances Co., Ltd. It states that the device is substantially equivalent to a predicate device (Solara, K012370) and meets applicable performance requirements specified in ANSI/RESNA WC Vol. 1 Sec. 1. Sec.5, Sec.7, Sec.8, Sec.15, Sec.16, and California Bureau of Home Furnishings 117. This refers to physical and mechanical testing standards for wheelchairs, not AI performance.

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