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510(k) Data Aggregation

    K Number
    K982849
    Device Name
    PANTHER WHEELCHAIR
    Manufacturer
    SNUG SEAT, INC.
    Date Cleared
    1998-10-05

    (54 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

    The Panther Wheelchair is designed for children and/or small adults who have physical impairments that require the use of a device to assist them with their mobility needs.

    Device Description

    Panther Wheelchair

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a wheelchair. It does not contain the specific information requested about acceptance criteria and a study proving device performance for an AI/ML powered device. The letter is for a physical medical device (Panther Wheelchair) and focuses on substantial equivalence to existing devices and regulatory compliance, not algorithmic performance.

    Therefore, I cannot extract the requested information from the provided text.

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