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510(k) Data Aggregation

    K Number
    K052586
    Date Cleared
    2005-12-09

    (80 days)

    Product Code
    Regulation Number
    890.3850
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The A&I Pediatric Wheelchairs are intended to provide mobility to persons, primarily children, who may be limited to a sitting position.
    The A&I Bariatric Wheelchairs are intended to provide mobility to persons, primarily larger adults, who may be limited to a sitting position.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer for wheelchairs. It confirms the substantial equivalence of the wheelchairs to previously marketed devices and outlines regulatory requirements.

    This document does not contain information about the acceptance criteria or a study proving a device meets acceptance criteria. It is a regulatory approval letter, not a scientific study report. Therefore, I cannot extract the requested information.

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    K Number
    K010094
    Date Cleared
    2001-02-15

    (35 days)

    Product Code
    Regulation Number
    890.3850
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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