LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K091880
    Device Name
    CLAYTON INTRA-AURAL DEVICE (CID)
    Manufacturer
    ASCENTIA HEALTH INCORPORATED
    Date Cleared
    2010-02-24

    (245 days)

    Product Code
    MQC
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ASCENTIA HEALTH INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CID is indicated as an aid in reducing temporomandibular disorder (TMD) pain.
    Device Description
    The CID is comprised of a pair of small, hollow, ear inserts made of medical grade polymers that is custom-fit to each subject's ear canals. It is constructed from methacrylate polymers and similar rigid plastics that have been safely used in commercially available hearing aids for decades. The CID is designed to rest in the outer third of the ear canal and has a small retraction post that allows for ease of removal of the device from the ear canal. It is designed to conform to the shape of the ear canal when the jaw is in a slightly open position.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1