LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K020227
    Device Name
    SELICOR, MODELS A100 & D100
    Manufacturer
    SELICOR, INC.
    Date Cleared
    2002-07-30

    (189 days)

    Product Code
    IMJ
    Regulation Number
    890.5290
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    K173300
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Diathermy Component. To generate deep heating within-body tissues for the treatment of conditions such as relief of pain, muscle spasms, and joint contractures.

    Device Description

    Selicor Models A100 and D100

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA to Selicor, Inc. regarding their Shortwave Diathermy Devices, Models A100 and D100. It confirms that the devices are substantially equivalent to legally marketed predicate devices.

    This document does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. It is solely an FDA clearance letter. Therefore, I cannot provide the requested information based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1