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510(k) Data Aggregation

    K Number
    K981418
    Device Name
    TC SERIES (TRANSPORT)
    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 (Transport) are not for self-propelling but, 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 (Transport) [Mechanical Wheelchair]

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a series of mechanical wheelchairs. It confirms the substantial equivalence of these devices to previously marketed devices and permits marketing.

    The document does not contain any information about:

    • Acceptance criteria for device performance.
    • A study proving the device meets acceptance criteria.
    • Sample sizes, data provenances, expert qualifications, or adjudication methods for a test set.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies or their effect sizes.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • Training set sample size or how ground truth was established for a training set.

    Therefore, I cannot fulfill your request based on the provided input.

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