אישור FDA

and besides, these days we tried our best to see if can help you something about the FDA, as Perfect idea has the FDA510K, we talked with them and put Marvelous Device into the list, I hope this can be helpful to you.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=947283&lpcd=OLP