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510(k) Data Aggregation

    K Number
    K141524
    Device Name
    NEURO-AUDIO
    Manufacturer
    TELEEMG, LLC USA
    Date Cleared
    2015-03-12

    (276 days)

    Product Code
    EWO, GWJ
    Regulation Number
    874.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    TELEEMG, LLC USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neuro-Audio system is indicated for use in the recording and analysis of human physiological data used for the diagnosis of auditory and hearing-related functions. It is intended as an aid to healthcare professionals trained and skilled in audiology. The system assists in the evaluation and diagnosis of ear disorders in humans using evoked potentials (EP), electrocochleography (ECochG), auditory brainstem response (ABR), auditory steady-state response (ASSR), otoacoustic emission (OAE) and pure tone audiometry (PTA). The device is intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories. The patient group includes all ages and genders.
    Device Description
    The Neuro-Audio system provides for audiology biopotentials recording and input to personal computer (PC) by 1-2 channels, and measurement, calculation and analysis of its parameters. It can be used in patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories of the research institutions for auditory tract study and brain functional state study. General functionalities provided by the system are: - biopotentials acquisition by 1-2 channels in any unshielded room - auditory stimulation - electrocochleography (ECochG) acquisition - auditory brainstem response (ABR) acquisition (air and bone conduction) - middle- and long-latency auditory evoked potentials (AEP: MLR, LLR) acquisition - cognitive evoked potentials (MMN, P300) acquisition - auditory steady-state response (ASSR) acquisition - otoacoustic emission study using transient evoked otoacoustic emission (TEOAE) and distortion product otoacoustic emission (DPOAE) - spontaneous otoacoustic emission study (SOAE) - pure tone audiometry (PTA; air and bone conduction) - exam report generation - review, store, and print of the recorded traces, results of their analysis and exam reports. In addition, the Neuro-Audio system provides the healthcare professional with: - A means of adjusting or activating all of the unit's settings and controls. - Multiple ways in which a user can carry a task, such as from a menu, using the mouse or the keyboard or by double-clicking on an icon. - Configurable function keys and fields that enable the user to customize the interface to meet their requirements. - Single-stroke keyboard function keys for key tasks carried out during a patient examination.
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    K Number
    K102610
    Device Name
    FOCUS EMG DEVICE
    Manufacturer
    TELEEMG, LLC USA
    Date Cleared
    2011-03-04

    (175 days)

    Product Code
    IKN, JXE
    Regulation Number
    890.1375
    Why did this record match?
    Applicant Name (Manufacturer) :

    TELEEMG, LLC USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Focus is intended for use by a healthcare provider to perform nerve conductions and EMG studies as an aid in the evaluation of patients with diseases of muscle and nerves. The machine can also use electrical stimulus or sound stimulus for evoked potentials (EP) studies.
    Device Description
    The Focus is a 2-channel neurodiagnostic testing system designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular systems in a clinical environment. The system enables the healthcare provider to perform evoked potentials, nerve conductions and needle EMG studies as an aid in the evaluation of patients with central and peripheral nervous system symptoms. The device provides functionality for the Electromyography (EMG), Nerve Conduction Studies (NCS), and Evoked Potential (EP) testing for a range of clinical applications and has a fast, intuitive and flexible graphical user interface (GUI) that conforms to a Windows philosophy. The Focus EMG Device consists of a handheld electronic unit, a stimulator unit with steel electrodes and felt pads, and a footswitch.
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