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510(k) Data Aggregation

    K Number
    K090284
    Device Name
    RES-Q INFANT WEDGE AND SLING
    Manufacturer
    CR ENTERPRISES, LLC.
    Date Cleared
    2009-06-05

    (120 days)

    Product Code
    FRP
    Regulation Number
    880.5680
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K905629,K932636
    Predicate For
    K172962
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The RES-Q Infant Wedge & Sling is designed to allow babies 0-12 months with gastroesophageal reflux to rest comfortably in a semi-upright position; it is used for sleeping and playtime in supine, prone, and side-lying positions.

    Device Description

    Device Name: RES-Q Infant Wedge & Sling
    Classification/Common Name: Holder, Infant Positioner
    Code FRP, CFR 880.5680
    Class 1

    AI/ML Overview

    The provided text is a 510(k) summary for the RES-Q Infant Wedge & Sling, which is an infant positioner. It does not contain information about a study with acceptance criteria, reported device performance, or details typically associated with the evaluation of AI/ML devices or diagnostic tools.

    The document states: "FDA has not established special controls or performance standards for this device."

    Therefore, I cannot provide the requested information from the given text as it is not present. This device is a Class I medical device, which typically has lower regulatory scrutiny and does not require extensive performance studies and acceptance criteria as would be expected for a diagnostic or AI-powered device.

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