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# Dynavision D2 Adulterated and Misbranded: FDA
- URL: https://www.fdaweb.com/dynavision-d2-adulterated-and-misbranded-fda/
- Published: 2017-09-12T12:00:00.000Z
- Updated: 2026-09-14T22:49:08.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139598

A 4/18-4/26 FDA inspection at Dynavision International, West Chester, OH, determined that the firm is the specification developer and complaint handling unit for the Dynavision D2 attention task performance recorder. A 9/5 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574774.htm?ref=fdaweb.com) says the firm’s Web site gives examples of therapeutic claims that render the D2 adulterated because the company does not have an approved PMA application or IDE application for the device as described and marketed. The D2 also is misbranded, the letter says, because it entered interstate commerce for commercial distribution with major changes or modifications without submitting a new premarket application.

The letter notes that a previous model, the Dynavision 2000, was given 510(k) clearance for an indication of reaction time measurement. However, the letter says, the firm’s promotion of the D2 device provides evidence that it is intended for a number of indications not cleared under the 510(k), which would constitute a major change or modification to its intended use, for which the firm lacks clearance or approval.

FDA says the firm’s therapeutic claims relate to stroke, traumatic brain injury, visual-motor and other neurocognitive conditions, Parkinson’s disease, driver rehabilitation, and fall prevention. Also, it says, a diagnostic claim that exceeds the cleared diagnostic claims related to the measurement of reaction time is neuro-cognitive evaluation for concussion management.

The company was told to immediately cease activities that result in the misbranding or adulteration of the Dynavision D2 device, such as the commercial distribution of the device for the uses discussed in the letter.

FDA also says the inspection identified Quality System Regulation violations including: 

- failing to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements; and
- failing to establish and maintain procedures to control the design of the device to ensure that specified design requirements are met.

Dynavision was told to take prompt action to correct the violations and to respond with a list of specific steps taken to correct the violations and prevent their recurrence, documentation of each of the steps, and a timetable for completion.