App may Require FDA Approval

This is not unexpected as the article in CW implies.   Just because it is an App does not mean that the public does not need protection against medical scams.

NeuroMetrix's forthcoming app may require FDA approval
The Food and Drug Administration has said it doesn’t want to get involved with health-related apps. A forthcoming product from NeuroMetrix, the maker of the Quell device, might change that.
Enter NeuroMetrix. It is a publicly traded company that recently launched Quell, an over-the-counter device that uses electrical nerve stimulation to manage pain.  ... 

Quell, briefly, works with the body's sensory nervous system to send neural pulses to the brain, triggering pain relief. The device is calibrated to provide the exact amount of relief needed and to work 24/7 — that is why NeuroMetric designed it to wrap around the calf. Quell also comes with a smartphone app for the users to track their therapy.... "