Tampa, FL - (NewMediaWire) - November 18, 2020 - REMSleep Holdings, Inc. (OTC PINK: RMSL) Gives an update on FDA process. We have had numerous inquiries regarding REMSleep regulatory status. The new Deltawave nasal pillows mask evolved from the company's original 510K and CPAP mask, Laminair. For an extended period, it was the company's understanding the new Deltawave CPAP interface would be covered under our original "Laminair" 510K with a name change and notifications of insignificant material/design changes and features represented in our original 510K. After repeated reviews from the company's FDA consultants the company was informed the improvements to the Deltawave were too extensive, superimposed with recently added regulations, which would require filing a new 510K. The company was stunned by this revelation. The company has since exhausted every means possible to a pathway of using the company's original 510K. We have been silently working/struggling to give this good news.
REMSleep has now passed through the grieving process and has initiated the steeper regulatory hill climb. All regulatory demands are in progress. This we can guarantee. REMSleep takes full responsibility for these delays and disappointments. We can only hope we can be forgiven by investors who have had faith in our company. The degree of despair is incredible. The company has a wonderful product. At least 90% of all patients testing our product give outstanding reviews. We know it is a wonderful product, otherwise, we would not have the will to fight this victory fight. We know Deltawave will change the lives of so many and we have to make Deltawave available for those who need to be rescued from a long standing scourge. Stand with us and be a part of this victory.
About REMSleep Holdings, Inc.
REMSleep Holdings, Inc. is a medical device manufacturer dedicated to forever changing the level of treatment provided to obstructive sleep apnea patients. Our focus is primarily designing and manufacturing devices and products for the treatment of sleep apnea and other respiratory conditions. With over 30 years of collective experience in CPAP therapy, the REMSleep team has extensive knowledge and understanding of CPAP and the challenges of patient compliance. We diligently strive for our products to make a difference and improve the condition of those suffering from sleep apnea.
REMSleep Holdings, Inc. has a new patent pending, innovative sleep apnea product that will meet multiple market demand and be able to reach and address a large percentage of the patient population who continue to struggle with CPAP compliance.
This press release may contain forward-looking statements regarding the Company. All statements, other than statements of historical fact included herein, are "forward-looking statements" including statements regarding the Company’s future prospects and risks in investing in Company’s common stock. These statements are based upon the Company's current expectations and speak only as of the date hereof. Financial performance in one period does not necessarily mean continued or better performance in the future. The Company's actual results in any endeavor may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, which factors or uncertainties may be beyond our ability to foresee or control. Other risk factors include the status of the Company's common stock as a "penny stock" and those risk factors stated in reports filed with the U.S. Securities and Exchange Commission or “SEC” on its EDGAR website (URL: www.sec.gov).
REMSleep Holdings, Inc.
2202 N. West Shore Blvd.
Tampa, FL 33607