Focus has posted a new page on their site which directs new users to show caution in their use of DIY tDCS. Focus goes so far as to caution people under the age of 18 not to try it.
If you are under 18 you should stop here. tDCS is not suitable for children and should not be used. This is because your brain is still developing and you don’t need to mess with its neuroplasticity.
The page goes on to list the known risks and a few benefits. Interestingly, it does not mention depression. I would have to imagine due to the possibility of crossing that nebulous regulatory line around ‘medical devices’.
Focus is, as I understand it, in the midst of fulfilling orders for their GoFlow device. You can read a full review of the GoFlow on SpeakWisdom, the (primarily) tDCS-related site authored by Dr. Brent Williams. Go Flow Pro, Nice Brain Stimulation Kit!
New Go Flow Pro package.
Focus obviously cannot state anything regarding medical conditions. That would bring the wrath of the FDA on them, causing them to be banned from the market.
Agreed. Focus have been careful all along. As Anna Wexler points out in our interview, it’s a very wriggly line and in a state of flux at the FDA. For example, their new General Wellness: Policy for Low Risk Devices – Draft Guidance for Industry and Food and Drug Administration Staff(pdf)