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510(k) Data Aggregation

    K Number
    K113065
    Device Name
    RL, UL, SL, EL, AND EPL VERTICAL PLATFORM LIFTS
    Manufacturer
    BELLA ELEVATOR, LLC
    Date Cleared
    2012-02-22

    (131 days)

    Product Code
    ING
    Regulation Number
    890.3930
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K061514,K091881,K960739,K033469
    Why did this record match?
    Reference Devices :

    K061514, K091881, K960739, K033469

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

    The Bella Elevator, LLC vertical Platform lift models RL, UL, SL, EL, EPL are designed to transport persons with a mobility disability either in a wheelchair or ambulatory, up and down between levels of a residential or public facility.

    Device Description

    The Bella Elevator, LLC vertical platform lift models RL, UL, SL, EPL are designed to transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility. The model EL and EPL are located within with their own integrated enclosure. The model SL is located within a hoistway. The UL model is unenclosed, other than guarding around the platform area. The RL model is unenclosed and intended for applications found in a residence. These models are designed for both indoor and outdoor applications. Each referenced model has a capacity of 750 lbs to accommodate a person in a wheelchair and an attendant. The lifts are available with a chain hydraulic drive system or an acme screw drive system. Backup systems are available for emergency operation and evacuation. All controls are low voltage, constant pressure. Use may be restricted to authorized persons with key switch located on control panels.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (Vertical Platform Lifts) and related FDA correspondence. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically associated with AI/software medical device submissions (e.g., performance metrics like sensitivity, specificity, AUC).

    The documentation focuses on the device description, intended use, and its compliance with established national safety standards for physical devices. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving their fulfillment as per your prompt's structure, which is designed for AI/software-based devices.

    The "Performance Data" section in the document states: "The Bella Elevator, LLC Vertical Platform Lift models RL, UL, SL, EL, and ELP fully comply with the applicable sections of the following National Safety Standards:

    • ASME A18.1- Safety Standard for Platform Lifts and Stairway Chairlifts
    • ASME 17.5- Electrical Code for Elevating Devices"

    This indicates that the "acceptance criteria" for this physical device are the requirements of these safety standards, and the "study" proving compliance is likely a series of engineering tests and demonstrations showing the device adheres to these standards. However, the document does not elaborate on specific metrics, sample sizes, ground truth, or expert involvement as requested for AI/software evaluation.

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