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510(k) Data Aggregation

    K Number
    K021910
    Device Name
    COMFORT DREAMRIDER SCOOTER, LY-EW402
    Manufacturer
    COMFORT ORTHOPEDIC CO. LTD.
    Date Cleared
    2002-10-11

    (123 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

    Device Description

    Not Found

    AI/ML Overview

    This document is related to a 510(k) premarket notification for a motorized three-wheeled vehicle (scooter). It does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth for a study. This is a regulatory clearance letter, not a study report.

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