They are very dangerous to operate. You're working with 100 percent O2 under pressure, so even little things like lotions/ perfumes that use a thinning product can cause combustion.
As far as enforcement.... There are only a couple different companies capable of making a chamber that can withstand 6 atmospheres of pressure safely, and they're all governed by CMS like other pieces of heavy duty medical equipment.
There's a lot of licensing and overwatch for medical equipment like this, if a company were to actually make one without going through the proper channels the companies and licensing orgs that have done their due diligence would come after them.