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510(k) Data Aggregation

    K Number
    K962834
    Device Name
    HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP
    Manufacturer
    HEELBO, INC.
    Date Cleared
    1996-10-18

    (88 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP

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

    Heelbo Ouilted Limb Holder with Double D-Ring. Ouick-Release Snap, and Strap is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting positions.

    Device Description

    Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap is a disposable quilted limb holder with a Velcro® fastener, Double D-Ring, Quick-Release Snap and Straps that secure to a bed, gurney, chair or wheelchair. The Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The Heelbo Quilted Limb Holder allows for wrist adjustment to provide a secure fit without cinching. The Double D-Ring is simple to use and allows the caregiver easy access to the patient. Also, the adjustable Double D-Ring and Quick-Release Snap allow for supine and sitting positions. The Heelbo Quilted Limb Holders are machine washable.

    The Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap is available in the following sizes:

    Stock No. 9350 Small-Regular / cuff size: 11 1/2" long strap: 3/4" wide, 60" long

    Stock No. 9360 Large-X-Large / cuff size: 13 1/2" long strap: 3/4" wide, 60" long

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification summary for a medical device (Heelbo Quilted Limb Holder), focusing on its intended use, description, and substantial equivalence to a predicate device. It addresses aspects like technological characteristics and biocompatibility based on material history of safe use, but it does not detail specific performance metrics, clinical studies, or expert evaluations as requested in the prompt.

    Therefore, I cannot extract the information needed to fill out the table and answer the questions about acceptance criteria and a detailed study.

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