RemSleep crosses milestone
By HME News Staff
Updated 10:54 AM CDT, Tue September 5, 2023
TAMPA, Fla. – RemSleep has successfully passed testing protocol for 510K clearance of its DeltaWave CPAP mask, including cytotoxity and MLA tests, which were the subject of past issues requiring retesting. The company now expects submit for 510k clearance with the U.S. Food and Drug Administration before the end of September. "This is a substantial and critical milestone for RemSleep and the DeltaWave mask,” said CEO Tom Wood. “It has taken significantly longer to get to this point than we had ever envisioned due to the unforeseen delays and administration issues, but in the end, the successful results demonstrate what we have confidently stated and believed from the start: The DeltaWave mask, and the materials used in the manufacture of the mask, are safe.” RemSleep, which also makes a CPAP device called ResPlus, says it continues to reach out to distributors and channel partners for DeltaWave’s eventual launch. The company says it will apply lessons learned to its next generation of masks. “While this has been a tough learning curve, we expect to be able to employ the knowledge gained to move our next generation masks through the clearance process and into the market significantly faster and with less expense,” Wood said.
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