The regulations don't just disappear to allow for such imports as in your example ...?
My point is the regulations are leading to the duopoly, which is the source of the problem. The last private-equity owner seems to have been fine. And the market was competitive before the CMS rules in 2005. I’m not suggesting scrapping the rules. But the rules are clearly well past safety.
> how would it fix things then if it wasn't private equity dominating that market?
The visible answer is clearly contingent on some future regulatory landscape coming into existence, otherwise it makes no sense, so I was wondering how does it answer the original question?
The dumb thing is these super cheap wheelchairs would likely cost the end users more money than the expensive ones as they will buy them out of pocket vs having their insurance/medicare cover most/all of the cost.
The reason these companies don't sell these wheelchairs in the US is likely because the marketing would run afowl of regulations about selling medical devices. You probably could sell these as bicycles and hobby chairs though.
This is something I've never really understood. Wouldn't the insurance company be ever grateful to you if you accepted a non-medical wheelchair because it's 1/10th the cost. Hell, have 5! Is there any reason insurance can't pay for them?
Also, medical insurance is supposed to cover bona fide medical treatments and supplies. So this likely bumps up against regulation again. If something goes wrong with the out-of-regulation device that insurance paid of as if it were a medical wheelchair (e.g. safety incident leading to injury), they could be liable.
It's the same as why dental insurance won't pay for your next door neighbor handyman to pull out your tooth with a pair of pliers.
Can the FDA stop a person from using one by coming to their home and confiscating it?