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510(k) Data Aggregation

    K Number
    K063320
    Manufacturer
    Date Cleared
    2007-02-27

    (117 days)

    Product Code
    Regulation Number
    890.3860
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13)

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

    The intended use of the Vision (P13) lift wheelchair is to provide forward and reverse mobility and up and down movement for greater accessibility to surroundings. This chair is designed for occupants weighing up to 350 pounds, whom have the capacity to operate a standard joy stick hand control.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for an "Electric Powered Lift Wheelchair, Model Vision (P13)". This document describes the device, its intended use, and the FDA's marketing approval. However, it does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the device's performance.

    Therefore, I cannot provide the requested information. The document focuses solely on the regulatory approval process and not on the technical performance data that would typically be generated for a device study.

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