I am developing a small, battery powered device which will play sounds
through headphones which is intended to help people sleep. The sounds
themselves are somewhat special and there is some data and testing
which attests to their therapeutic value in aiding sleep (mostly from
the developer of the sounds), but it is definitely not a 100% provable
phenomenon, and anyone could easily make a case that the sounds do
nothing.
My question is, what approvals do I need to sell this device in the
USA? It will be sold for around $20 in large quantities, probably
around 1 million units (yes I am optimistic). Is this device
considered a medical device since its for helping people sleep, and
therefore needs FDA approval? The FDA guidelines seem to include every
electrical device ever made since they say "anyting emitting
non-ionizing radiation". I am almost certain FCC approval will be
required since this device will emit some kind of interference simply
because its electronic. And what about UL approval? And anything else?
This device is electrically similar (if not identical) to a walkman,
but with the added complexity (from an approval standpoint) that it
will be sold as a therapeutic aid to help people fall asleep.
So, my question is: what approvals will this device need to be sold in
the USA, and how much will they cost, and how do I get them approved?
If the price seems too low please let me know and I will adjust it.
Please feel free to ask any questions, I will answer them ASAP. |
