RemSleep Holdings Inc (RMSL)

[AliasIsAlreadyInUse]

510(K) denied, not surprised. If you look at the 10 year old mask it was using as the basis of improvement, the two look nothing alike. Personally, I thought the Deltawave looked too advanced to base the 510(K) on the Laminair design just from pictures. I'm neither expert, nor sufferer of sleep apnea, just a side by side of Deltawave and Laminair pictures inspired doubts. I'm not pumping or dispelling RMSL failures in progress but a simple comparison between Deltawave and Laminair a laymen could see 510(K) would be denied. I think they missed the forest for the trees and are behind the times on the FDA side and the company management side. They probably have something good with the Deltawave.