An Ohio company violated federal regulations for medical devices by making claims for its product that were not approved by the FDA, the agency said in a warning letter.
The company, Dynavision International, of West Chester, had received FDA approval for its Dynavision 2000 product as a device that measured reaction time. But it ran afoul of the regulations when it introduced an updated model, the Dynavision D2, and made claims on the company web site that went beyond the approved indication, the letter said.
The expanded claims concerned the ability of the Dynavision D2 to measure cognitive, visual and physical impairment related to stroke, Parkinson’s disease, traumatic brain injury and other conditions and to assist in concussion management and in “return to play” decisions for athletes, the FDA said.
The warning letter also faulted the company for its failure to comply with quality-control procedures required for medical device manufacturing.