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RemSleep Holdings Inc. Announces Completion of DeltaWave CPAP Mask
RemSleep Holdings Inc. Announces Completion of DeltaWave CPAP Mask.
About this update from Remsleep Holdings, Inc.
[{"type":"text","content":"TAMPA, FL / ACCESSWIRE / September 1, 2023 / RemSleep Holdings Inc. (OTCQB:RMSL), a medical device manufacturer dedicated to forever changing the level of treatment provided to Obstructive Sleep Apnea (OSA) patients, provides an update on its testing protocol for 510K clearance of its DeltaWave CPAP Mask.RemSleep has completed the testing protocol for 510K clearance and all tests have successfully passed including the Cytotoxicity and MLA tests which were the subject of past issues requiring retesting. The company previously provided an estimate of 3-6 weeks for compiling these results and has reduced that estimate to 2-4 weeks before submitting to the FDA for 510K clearance.RemSleep CEO, Tom Wood, commented: "This is a substantial and critical milestone for RemSleep and the DeltaWave mask. 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. It has been a frustrating road with so many issues coming out that were beyond our control, but the testing is over and we expect to submit to FDA before the end of September. During this extended time, we secured a design patent for the DeltaWave, made significant progress on the development of the next generation masks, and have continued to reach out to distributors and channel partners for the eventual product launch. 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 & with less expense.We would like to thank our investors for their continued support and invite new investors to visit our website at www.remsleep.com for more information on how the DeltaWave goes beyond the normal sleep apnea mask for performance. There is an informational video on the key points of difference as well as testimonials from users and clinicians on what these PODs mean to real world sleep and productivity for DeltaWave users. Finally, for those still affected by the CPAP recalls and shortages, we have our ResPlus CPAP device available for purchase via our website."The ...