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510(k) Data Aggregation

    K Number
    K991313
    Device Name
    ACCUTRED SHOE
    Manufacturer
    ORTHOPEDIC TECHNOLOGY RESEARCH, INC.
    Date Cleared
    1999-06-23

    (68 days)

    Product Code
    IRN
    Regulation Number
    890.5575
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ACCUTRED SHOE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AccuTread™ Shoe System is intended for use as a limb load monitoring device to assist in the rehabilitation of patients with insults to their lower extremities. The AccuTread™ Shoe System is intended to be used in any situation in which a therapist and/or patient would benefit from objectively assessing the amount of weight that is being applied to a lower limb.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the AccuTread Shoe System. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It outlines regulatory requirements and contact information for further questions.

    Therefore, I cannot provide a detailed response to your request, as the necessary information is not present in the provided text.

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