The guy in the photo is thinking "Why did they strap all this crap to me? Where did I put my damn wheelchair.."
Sweet. If my leg goes to total shit I can just be a cyborg.
If I had one I'd make it sound like the power loader from Aliens...
WTF does the fda need to approve something that you strap on like a back pack?
Because they can, and because it raises the cost of the system by at least one zero.
I had an encounter with the medical tech prices when rehabilitating my broken shoulder. The assistive rigs were up to 100 times more expensive than what I'd consider a reasonable cost. Made me thinking about something like Thingiverse, but for designs of medical/assistive/rehab tech; so in case of need there is no reason to go the Approved Way and shell out money that aren't available, but just visit your nearest locksmith and get it cut/welded together and get the motors and microcontroller attached. Or get the parts 3d-printed, possibly customized to your own body by entering either the measurements or even a 3d scan of the person or body part.
The Healthcare Industry won't like it, but we wouldn't have those $1-a-pop tracks on iTunes without Napster too. So don't ask for approval and roll it out, possibly in some obscure jurisdiction outside of the Big Med lawyers' reach.
The FDA has regulatory power over the production and sale of products that are classified as "physical medicine devices" including things like canes and wheelchairs.
Though it's not explicit, I'm pretty sure the guy in the photo is the inventor.
Because just like drugs, devices can be utter bullocks and either do nothing, or worse, hurt someone it is supposed to help. Thus the oversight where something like this has FDA approval, and shit like magnetic bracelets do not.
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