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510(k) Data Aggregation

    K Number
    K070729
    Device Name
    BALANCEBACK MOBILE INTUITIVE VNG SYSTEM
    Manufacturer
    FALL PREVENTION TECHNOLOGIES, LLC
    Date Cleared
    2007-03-30

    (15 days)

    Product Code
    GWN
    Regulation Number
    882.1460
    Why did this record match?
    Applicant Name (Manufacturer) :

    FALL PREVENTION TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The balanceback ™ Mobile Intuitive VNG device is intended for recording, viewing, and analyzing eye movements in support of identifying balance disorders in human subjects. The Mobile iVNG is intended for use only by trained physicians or clinicians in an appropriate doctor's office or health care facility. This device provides no diagnoses nor does it provide diagnostic recommendations.
    Device Description
    Eye movements have long been known to provide important clues to the identification and location of balance disorders. Physicians and other clinicians employ the VNG system to conduct a set of established, well-known and well-documented eye movement tests. The results of the VNG eye movement tests are combined with other clinical information so that the attending clinicians may render findings on the health of the patient's primary balance sensors and related balance processing system. Using the Mobile VNG, clinicians guide patients through a series of eye movement tests. A testing battery (i.e., an examination) typically consists of all eight tests supported by the VNG: caloric, positional, Hallpike, gaze, saccades, smooth pursuit, optokinetic, and highfrequency head shake. The attending physician may select one, several, or all tests, and has full flexibility in determining the sequence of the tests to be performed. The patient under examination wears the iVNG goggles contain one IR light source and one IR camera for each eye. The IR video cameras sense the infrared signal reflected from the eyes and create a continuous monochromatic (grayscale) video motion picture stream of the eyes. The infrared signal is used because the human eye cannot detect the presence of the infrared signal and therefore this illumination does not create perturbations in measurements of eye movement. Measurements may therefore be made both in the presence and in the absence of visible light, thus providing clinicians with maximum flexibility for making measurements in a wide variety of situations. The video stream from the IR cameras is digitized and transferred into the memory of the digital computer where signal processing software tracks, records, analyzes and displays eve movements for the attending clinician. The Mobile iVNG system makes appropriate calculations and presents reports of well-known and well-documented parameters associated with each eye movement test. Some eye tests require the patient to follow a visual stimulus. A projector, controlled by the iVNG hardware, displays stimuli on any light-colored surface, such as a wall or projection screen. The goggles and Mobile iVNG software record the patient's eve movements while he/she follows the stimulus.
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    K Number
    K042529
    Device Name
    BALANCEBACK VNG SYSTEM
    Manufacturer
    FALL PREVENTION TECHNOLOGIES, LLC
    Date Cleared
    2004-10-06

    (19 days)

    Product Code
    GWN
    Regulation Number
    882.1460
    Why did this record match?
    Applicant Name (Manufacturer) :

    FALL PREVENTION TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BalanceBack VNG device is intended for recording, viewing, and analyzing eye movements in support of identifying balance disorders in human subjects. The VNG is intended for use only by trained physicians or clinicians in an appropriate doctor's office or health care facility. This device provides no diagnoses nor does it provide diagnostic recommendations.
    Device Description
    Eve movements have long been known to provide important clues to the identification and location of balance disorders. Physicians and other clinicians employ the VNG system to conduct a set of established, well-known and well-documented eye movement tests. The results of the VNG eye movement tests are combined with other clinical information so that the attending clinicians may render findings on the health of the patient's primary balance sensors and related balance processing system. Using the VNG, clinicians guide patients through a series of eye movement tests. A testing battery (i.e., an examination) typically consists of all eight tests supported by the VNG: caloric, positional, Hallpike, gaze, saccades, smooth pursuit, optokinetic, and high-frequency head shake. The attending physician may select one, several, or all tests, and has full flexibility in determining the sequence of the tests to be performed. The patient under examination wears the VNG goggles. The goggles contain one IR light source and one IR camera for each eye. The IR video cameras sense the infrared signal reflected from the eyes and create a continuous monochromatic (grayscale) video motion picture stream of the eyes. The infrared signal is used because the human eye cannot detect the presence of the infrared signal and therefore this illumination does not create perturbations in measurements of eye movement. Measurements may therefore be made both in the presence and in the absence of visible light, thus providing clinicians with maximum flexibility for making measurements in a wide variety of situations. The video stream from the IR cameras is digitized and transferred into the memory of the digital computer where signal processing software tracks, records, analyzes and displays eye movements for the attending clinician. The VNG system makes appropriate calculations and presents reports of well-known and well-documented parameters associated with each eye movement test. Some eye tests require the patient to follow a visual stimulus. A projector, controlled by the VNG software, displays stimuli on any light-colored surface, such as a wall or projection screen. The goggles and VNG software record the patient's eye movements while he/she follows the stimulus.
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