Is Flow Treatment safe?

In the clinical trial that supported FDA approval , side effects were compared against a headset that looked and felt identical but delivered no treatment. Apart from redness at the pad site, most reported effects happened at close to the same rate in both groups. Skin irritation, for example, was reported by 6.9% of people using Flow Treatment and by none of those using the sham headset.

The main risks are skin dryness, skin irritation or redness after prolonged use, transient headache, and stinging, burning or itching at the pad site. Skin burns can happen, and in the trial the two cases both involved pads that had dried out. That is why the instructions say to use fresh, damp pads every time.

Do not use Flow Treatment where there is broken or damaged skin at the pad sites, or metallic skull reconstruction at the pad sites.

Tell your clinician before you start, or at any point during treatment, if you are pregnant or think you might be; if you have thoughts of suicide or of harming yourself; if you have had epilepsy, seizures or unexplained blackouts; if you have a problem with your skull or metal in or around your brain; or if you have a long-term skin condition on your forehead or scalp. 

Flow Treatment is FDA approved under PMA P230024, through the FDA's most rigorous device review pathway. 

Full safety information: http://www.flowneuroscience.com/en-us/safety/