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510(k) Data Aggregation

    K Number
    K980033
    Device Name
    FERNO HEALTHCARE RECLINE-A-BATH 2
    Manufacturer
    FERNO-WASHINGTON, INC.
    Date Cleared
    1998-04-21

    (106 days)

    Product Code
    ILJ
    Regulation Number
    890.5100
    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 Reclin-A-Bath 2 is indicated for use with patients to relieve pain and itching. The Reclin-A-Bath 2 is indicated for use with patients to aid in the healing process of inflamed and traumatized tissue. The Reclin-A-Bath 2 is indicated for use with patients to serve as a setting for the removal of contaminated tissue.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the Ferno Healthcare Recline-A-Bath 2. It indicates that the device has been deemed substantially equivalent to devices marketed prior to May 28, 1976.

    Based on the provided text, there is no information available about acceptance criteria, the study proving the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    The letter focuses on the regulatory clearance process, stating that the device is substantially equivalent and can therefore be marketed. It does not contain the detailed technical or clinical study data that would address the questions posed.

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

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