P10 Clone with pending 510(k)

Saw info about this company when I logged out and saw the news panel at the top.

https://remsleep.com/deltawave-desc/

The diffuser blows upwards unlike the P10.
There is handwaving about how they solved the air starvation "problem"

The mask was announced way back in 2016, filed 510(k) in Nov '21.

Maybe they will actually be selling it in another 6 years

(My brother is working at a startup, partnered with a major conglomerate, and been awaiting their 510(k) approval for 4 years already)

Where is this product made?
Out of curiosity, I looked up 510 k, and found this:

"FDA 510(k) Clearance Process

The vast majority of medical devices on the U.S. market were given the government’s green light in a process known as the 510(k), which requires no clinical trials and very little oversight. . . . "

The website doesn't specify where it's made.
I'd expect it's made overseas.
The company is FL based per site.

It looks like vaporware though.
Pre-order been ongoing since Oct 9, 2019 (as shown by google)

chunkyfrog wrote: ↑

Thu Mar 24, 2022 10:55 am

510(k), which requires no clinical trials and very little oversight

??? Not sure how that writer formed that opinion ...

510(k) clearance requires showing the device in question being equivalent to something already approved and in the market. Not that easily done, as experienced by the company where my brother works.

But FDA has a lot of "grandfathered" items because the agency was only formed in 1906.

Though FDA can trace its origins back to the creation of the Agricultural Division in the Patent Office in 1848, its origins as a federal consumer protection agency began with the passage of the 1906 Pure Food and Drugs Act. This law was the culmination of about 100 bills over a quarter-century that aimed to rein in long-standing, serious abuses in the consumer product marketplace.