RMSL - REMSleep 510(K) Submission
Trade/Device Name: DELTAWAVE Nasal Pillows System
Regulation Number: 21 CFR 868.5905
Regulation Name: Noncontinuous Ventilator (IPPB)
Regulatory Class: Class II
Product Code: BZD
Dated: October 4, 2023
Received: October 10, 2023
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
REMSleep Holdings, Inc. is a medical devicemanufacturer dedicated to forever changing the level of treatment provided toobstructive sleep apnea patients. Our focus is primarily designing andmanufacturing devices and products for the treatment of sleep apnea and otherrespiratory conditions. With over 30 years of collective experience in CPAPtherapy, the REMSleep team has extensive knowledge and understanding of CPAPand the challenges of patient compliance. We diligently strive for our productsto make a difference and improve the condition of those suffering from sleepapnea.
REMSleep Holdings, Inc. has a new patentpending, innovative sleep apnea product that will meet multiple market demandsand be able to reach and address a large percentage of the patient populationwho continue to struggle with CPAP compliance.
Forward-looking Statements.
This press release may contain forward-lookingstatements regarding the Company. All statements, other than statements ofhistorical fact included herein, are "forward-looking statements"including statements regarding the Companys future prospects and risks ininvesting in Companys common stock. These statements are based upon theCompany's current expectations and speak only as of the date hereof. Financialperformance in one period does not necessarily mean continued or betterperformance in the future. The Company's actual results in any endeavor maydiffer materially and adversely from those expressed in any forward-lookingstatements as a result of various factors and uncertainties, which factors oruncertainties may be beyond our ability to foresee or control. Other riskfactors include the status of the Company's common stock as a "pennystock" 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)
Contact:
REMSleep Holdings, Inc.
14175 ICOT Blvd
Suite 300
Clearwater, FL 33760
Email:twood@remsleep.com
Phone: 912-590-2001