It appears getting medical approval for a product in the US is even harder than in Germany .. a bit of a bummer for me .. I THOUGHT THIS WAS AMERICA?!?

Every orthotics facility I approach immediately asks for FDA approval (510k clearance) .. was aware of that but was hoping that people on the ground would be more like 'yeah blud, that s the official stuff .. but ain't nobody really does that 😅' .. but no .. Murica very strict in regards to medical device approval