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510(k) Data Aggregation

    K Number
    K082288
    Device Name
    HAIDA HD21
    Manufacturer
    JIANGYIN EAST CHINA MEDICAL TECHNOLOGY CO., LTD.
    Date Cleared
    2008-08-19

    (8 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K062888,K072027
    Why did this record match?
    Device Name :

    HAIDA HD21

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

    HAIDA HD21 powered wheelchair is intended for an indoor/outdoor power wheelchair that provides transportation for disabled or elderly persons limited to a seated position.

    It is a motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

    Device Description

    The HAIDA HD21 powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market.

    AI/ML Overview

    The provided text is a 510(k) summary for a powered wheelchair (HAIDA HD21). It does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

    The document primarily focuses on:

    • Device Identification: Trade name, common name, classification, and product code.
    • Predicate Devices: Identifying similar devices already on the market (CWD01 and KV10HB).
    • Intended Use: Describing the purpose of the powered wheelchair.
    • Device Description: Briefly outlining the design as similar to existing powered wheelchairs.
    • Substantial Equivalence: Stating that the HAIDA HD21 is substantially equivalent to the predicate devices and that any minor differences do not raise new safety or effectiveness concerns.
    • FDA 510(k) Clearance Letter: Formal approval from the FDA based on the substantial equivalence claim.
    • Indications for Use Statement: Detailed description of how the device is intended to be used.

    Since the provided text does not describe an active study or acceptance criteria, I cannot fill out the requested table and information. This kind of information is typically found in a "Performance Data" or "Clinical Data" section of a 510(k) submission, which is not present in the provided excerpts.

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