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510(k) Data Aggregation

    K Number
    K971568
    Device Name
    REST MATTRESS
    Manufacturer
    REST MATTRESS
    Date Cleared
    1997-07-18

    (80 days)

    Product Code
    FNM
    Regulation Number
    880.5550
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The REST Mattress is indicated for all patients highly susceptible to decubitus ulcers. The REST Mattress provides alternating pressure support for the prevention and management of these sores.

    Device Description

    REST Mattress

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for a device called "REST Mattress". It states that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information regarding acceptance criteria, device performance data, study design, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies. It is a regulatory approval letter, not a clinical study report.

    Therefore, I cannot provide the requested information based on the input text.

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