Search Results
Found 1 results
510(k) Data Aggregation
K Number
K182214Device Name
DizzyDoctor System 1.0.0
Manufacturer
DizzyDoctor Systems, LLC
Date Cleared
2018-09-14
(30 days)
Product Code
GWN
Regulation Number
882.1460Why did this record match?
Applicant Name (Manufacturer) :
DizzyDoctor Systems, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DizzyDoctor® System 1.0.0 Eye Movement Monitor is indicated for use in the medical office, and in the home setting for monitoring patients with a diagnosis of dizziness caused by peripheral vestibular disorders who are under the supervision of a physician. The device detects abnormal eye movements in standard positional maneuvers by recording, tracking, storing and displaying vertical, horizontal eye movements. This device provides no diagnosis and does not provide diagnostic recommendations.
Device Description
Dizziness and postural instability are common in patients in Otolaryngology practice. Accurate diagnosis and choice of treatment is hampered by difficulties in obtaining thorough histories and perceptions that physical examination is complex. The DizzyDoctor® System 1.0.0 broadens physician access to video recordings of abnormal eye movement disorders with an easily operated device for in-office use by health professionals and for in-home use by patients experiencing exacerbating episodes of dizziness outside the office setting.
Using mobile and web-based technology, The DizzyDoctor® System 1.0.0 allows recording of patient of abnormal eye movements in response to standard head positions used for monitoring peripheral vestibular disorders such as Benign Paroxysmal Vertigo. It consists of Vertigo Recording Googles (VRG) with a secure holder for the patient's iPhone Application for step-by-step audio instructions for medically-recognized Dix-Hallpike maneuvers, gyroscopic feedback for enabling correct head positioning, and accurate video-recording of eye movements in response to standard head positions used for assessing balance disorders.
The VRG secure docking station for the iPhone which aligns with the patient's pupil. The VRG has no direct electrical connection with external devices or equipment, and uses light from two LEDs during recording sessions. The VRG uses a standard iPhone compatible macro lens to adjust the focal length of the iPhone camera lens, and secures with a flexible headband.
Key components of the patient's iPhone support the DizzyDoctor® System 1.0.0 including: an accelerometer and gyroscope, a video camera, storage of video recordings, audio voice/speaker system for real-time interaction with the patient, standard software for downloading and playing mobile applications from external App vendors, software for web-based processes including uploading stored videos.
The DizzyDoctor® Mobile App provides audio support for step-by-step procedures in recording eye movements in relation to positional changes during self-testing, The DizzyDoctor® System is supported by a comprehensive web-based platform for secure patient and physician registration, as well as uploading, processing and downloading videos from the professional- and self-testing for abnormal eye movements. Processed videos are accessed and viewed by physicians on their desk-top office computers.
Ask a Question
Page 1 of 1