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510(k) Data Aggregation

    K Number
    K992779
    Device Name
    A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM
    Manufacturer
    MEDI-MAN REHABILITATION PRODUCTS, INC.
    Date Cleared
    2000-01-13

    (148 days)

    Product Code
    ILJ
    Regulation Number
    890.5100
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM

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

    Bath for the bathing of disabled persons.

    Device Description

    Not Found

    AI/ML Overview

    This is a letter from the FDA to Medi-Man Rehabilitation Products, Inc. regarding their A-2000 Bathing Systems; Hydrosonic Bathing System (K992779). The letter states that the device has been reviewed and determined to be substantially equivalent to devices marketed prior to May 28, 1976. This allows Medi-Man Rehabilitation Products to market the device.

    The document does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. It is a regulatory approval letter based on "substantial equivalence" to a predicate device, not a performance study. Therefore, I cannot provide the requested information.

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