My understanding is once you have FDA on your device, there is...

My understanding is once you have FDA on your device, there is still a certification process from the Federal Communications Commission required on manufactured samples before the product can be imported and sold in the USA.

https://device.report/fccid/2BCJXBPM1AT

I believe we have just been granted that certificate.



FCC IDs are usually shown on a label found on a certified radio frequency device and indicates that the device has received a FCC grant of certification. If a device has a built-in display, the FCC ID may be provided electronically. Any radio frequency equipment that is produced, sold or distributed in the US must have FCC certification. The label is often found on products sold outside the US because those products were either manufactured in the States and then exported or are also sold in the USA.