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510(k) Data Aggregation

    K Number
    K981949
    Device Name
    NUMOBAG
    Manufacturer
    NUMOTECH, INC.
    Date Cleared
    1999-02-03

    (245 days)

    Product Code
    KPJ
    Regulation Number
    878.5650
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For adjunctive therapy of the following conditions:

    • Skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions
    • Decubitus ulcers
    • Amputations/infected stumps
    • Skin grafts
    • Burns
    • Frostbite
    Device Description

    Numobag™

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the Numobag™ device, which primarily confirms that the device is substantially equivalent to a legally marketed predicate device for the stated indications for use.

    The letter does not include details about:

    • A table of acceptance criteria or reported device performance.
    • Sample sizes, data provenance, or ground truth establishment for any test or training sets.
    • Information about expert involvement, adjudication methods, or MRMC studies.
    • Results from standalone algorithm performance studies.

    The document's purpose is regulatory clearance based on substantial equivalence, not a detailed scientific study report.

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