LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K040679
    Device Name
    RICH-MAR AUTOPRISM INFRARED LAMP
    Manufacturer
    RICH-MAR CORP.
    Date Cleared
    2004-05-07

    (53 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RICH-MAR AUTOPRISM INFRARED LAMP

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

    The Rich-Mar AutoPrism is an infrared lamp as classified under 21 CFR Part 890.5500. As such, it emits energy to provide topical heating for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, and the relaxation of muscles; for muscle spasms, and for temporary relief of minor pain and stiffness associated with arthritis. For use when heat is indicated for the treatment of the fore mentioned conditions

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a specific medical device (Rich-Mar AutoPrism Infrared Lamp). It contains information about the regulatory classification, indications for use, and substantial equivalence to predicate devices.

    However, it does not contain any information about acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, ground truth establishment, or any kind of AI or algorithm performance study. The document is a regulatory communication, not a technical study report.

    Therefore, I cannot fulfill your request with the input provided.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1