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510(k) Data Aggregation

    K Number
    K991427
    Device Name
    PARAMED PARAFFIN WARMER
    Manufacturer
    DIVI INTL. CO.
    Date Cleared
    1999-08-13

    (112 days)

    Product Code
    IMC
    Regulation Number
    890.5110
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIVI INTL. CO.

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

    For use in temporary symptomatic relief of minor pain due to medically diagnosed arthritis and bursitis.

    Relaxes muscles, aids in the relief of stiff muscles, muscle spasms; helps to stimulate circulation.

    Device Description

    Paramed Paraffin Warmer

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Paramed Paraffin Warmer." It is not a study report and therefore does not contain information about acceptance criteria, device performance, study methodology, or ground truth establishment.

    The letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general control provisions.

    To answer your request, a different type of document, such as a "Premarket Approval (PMA) application," a "De Novo classification request," or a "clinical study report," would be needed. This document only confirms the regulatory clearance based on substantial equivalence.

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