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510(k) Data Aggregation

    K Number
    K981420
    Device Name
    TC SERIES (WIDE)
    Manufacturer
    GET A LIFE-GIVE A LIVING PLUS KIDS PROJECT, INC.
    Date Cleared
    1998-06-10

    (51 days)

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

    These manual wheelchairs are to be used by persons requiring assistance for mobility. The TC series (Wide) are for self-propelling or to be propelled by a care giver. These wheelchairs can be use for everyday in the home or outdoors, hospitals, or institution.

    Device Description

    TC Series (Wide) [Mechanical Wheelchair]

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a series of wheelchairs, including the "TC Series (Wide) [Mechanical Wheelchair]". It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

    The letter simply states that the FDA has reviewed the submission and determined that the devices are substantially equivalent to legally marketed predicate devices, allowing them to be marketed. It discusses regulatory classifications, general controls, and compliance, but not performance testing results.

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

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