Captain and others misguided by Captain's downramping (intended or otherwise),
I have just received this reply from the hard working MD in New Jersey (11.10pm). His response is as anticipated and should be salutary to posters who make negligent half-baked posts that probably alarm interested followers who don't have time to do the detailed research:
"Thanks for bringing this website to my attention, unfortunately there are a lot of cowboys in this industry and none of the devices on the website have FDA 510(k) clearance, actually they don’t even use the right language in propagating their lies as the FDA don’t approve anything, they clear devices but never approve anything. As for CE Mark, this is a self certification program hence it’s not difficult to obtain CE Mark clearance, it only becomes and issue if and when the authorities come to check your documentation to see if your device really stands up to CE Mark requirements"
HGR
unknown
