The Main Principles Of Dynavision D2 Brain Training
352(o), due to the fact that your company presented or delivered for intro into interstate commerce for business distribution of this device with major changes or modifications to the planned usage without submitting a new premarket alert to FDA as needed by section 510(k) of the Act, 21 U.S.C. 360(k), and 21 CFR 807.
Particularly, the previous model, Dynavision 2000, was cleared under K911938 with the indication for usage mentioned as "measurement of reaction time." Nevertheless, your company's promo of the gadget provides evidence that the gadget is planned for a number of indicators unclear under this 510(k), which would constitute a significant modification or adjustment to its desired use, for which your company lacks clearance or approval.
This includes any rehab declares associated to stroke. Examples include: o Cognitive Impairment including Deficits in Attentiono Physical Disability including Hemiplegia or Hemiparesis, and muscle paino Psychosocial Factors including Anxiety and Depressiono Visual Impairment including Hemispatial Disregard and Homonymous Hemianopsia, Traumatic Brain Injury (TBI)Visual-motor and other neurocognitive conditions, Parkinson's Diseaseo Physical Problems consisting of Resting Tremorso Gait Disturbanceso Psychosocial Elements consisting of Increased Danger of Depressiono Visual Impairmento Cognitive Problems consisting of Deficits in Executive Function, Memory, and Attention, Driver Rehabilitation, Fall Avoidance Neuro-Cognitive Examination for Concussion Managemento Consisting of suggested clinical interpretations related to "Return to Play" decisions.
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360(k), is deemed pleased when a PMA is pending prior to the agency (21 C.F.R. 807. 81(b)). The type of information that your firm requires to submit in order to obtain approval or clearance for the device is described on the Internet at http://www. fda.gov/ Medical, Devices/Device, Regulationand, Guidance/Howto, Market, Your, Device/default.
The FDA will examine the information that your company submits and choose whether the item might be lawfully marketed. Read More Here requests that Dynavision International, LLC immediately cease activities that result in the misbranding or adulteration of the Dynavision D2 device, such as the industrial circulation of the gadget for the usages discussed above.