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510(k) Data Aggregation

    K Number
    K061475
    Device Name
    ASTROTILT MANUAL WHEELCHAIR
    Manufacturer
    PDG PRODUCT DESIGN GROUP, INC.
    Date Cleared
    2006-06-14

    (15 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ASTROTILT MANUAL WHEELCHAIR

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

    To provide mobility to individuals limited to a sitting position.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding a mechanical wheelchair. It does not contain information about the acceptance criteria or a study proving device performance as it pertains to a software algorithm or AI-driven medical device.

    Therefore, I cannot provide the requested information based on the given text.

    The document is a regulatory approval letter for a physical product (a manual wheelchair), not a description of a study for a diagnostic or AI-driven medical device. The typical information requested (e.g., sample sizes, ground truth, expert qualifications, MRMC studies) are specific to the evaluation of software or AI performance, which is not applicable here.

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