Guest wrote:Den: Regardless of where it's sold and who sells it, it's STILL a medical device in the eyes of the FDA as well as any attorney that may be interested in where his client purchased it, should an undesired event occur.
Someone selling their used CPAP in a garage sale is simply asking for trouble and not a very smart individual.
THESE ARE MEDICAL DEVICES PEOPLE!
The FDA doesn't regulate USED medical devices. They regulate manufacturers. States have the option to regulate used medical devices and in fact, many states restrict who can buy such things as used X-ray machines. However, other than California, I have not seen any state regulate the sales of used xpaps. What states DO regulate is who is allowed to change the settings on the machines. I can tell someone how to change their settings, but other than an immediate family member, cannot make those changes myself because I'm not a state authorized person.
I would also add that it seems used oxygen concentrators are ALSO not regulated. In the past, it was impossible to get the replacement supplies needed, but seems you can do so now if you pay out of pocket. Yay!
Note: California lists xpaps as 'dangerous medical devices'
and it appears that this label remains attached even if you own the device. However, it could have been altered since then, so who knows (I don't live in CA, so not worth my time to pursue).
OK, I think we've given this old thread enough zombie life - it now glows!!