LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K963777
    Device Name
    HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100
    Manufacturer
    STEPHENSON INDUSTRIES, INC.
    Date Cleared
    1997-07-28

    (311 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
    • VENOUS STASIS S
    • DECUBITUS STASIS UL CERS
    • DIABETIC ULCERS
    • вики с
    • FROSTBITE
      -POST SURGICAL WOUNDS
    Device Description

    Hyper Pulse Intermittent Topical Oxygen Chamber, Models C-100; CB-100

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) letter for the "Hyper Pulse Intermittent Topical Oxygen Chamber" does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria.

    This document is a letter confirming the substantial equivalence of the device to a predicate device, allowing it to be marketed. It outlines the regulatory classification and general controls applicable to the device but does not detail any performance studies, test sets, ground truth establishment, or clinical effectiveness data.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1