CLEARWATER, FL - 
(NewMediaWire) - May 12, 2024 - REMSleep Holdings, Inc. (OTCQB: RMSL) gives an update on FDA 510(K) status.
We received the AINN Letter (FDA request for more information. The following is what we did to address FDA questions.
- Upon receiving FDA's questions, we conducted a full assessment of what was submitted vs. the Regulatory Requirements. We conducted the testing based on the current published regulatory requirements.
- We worked with our testing laboratory to answer FDA questions about biocompatibility testing.
- The requirements for 510(k) clearance are changing very quickly since the 2021 Philips CPAP & Bi-Level devices Recall & Post-COVID.
- We met with FDA 2 times to understand exactly the basis for their questions.
- Remsleep consulted with an EXPERT in the CDRH Divison responsible for RESPIRATORY DEVICES.
- FDA requested additional performance testing, or scientific rationale for some of the Performance Testing. Based on our evaluation of the scientific data we would need to put together it was less risky and more cost effective to conduct the additional testing.
- As a pre-emptive move, we retested (Exhaust Flow, Pressure Drop & CO2 Rebreathing before we initiated Accelerated Aging testing and then again after Accelerated Aging testing), plus Environmental Testing.
- We did an Accelerated Aging Study to establish a longer expiration date & we had to conduct the Performance Testing on the POST-AGED DW kits. The before and after testing took a little longer, but it was a decision we made for added insurance.
- All retesting has been completed and DW passed all criteria.
- Our date for submission to FDA is 5/24/24. HOWEVER, we have an FDA deadline of 5/31/24.
- As we have addressed ALL the FDA questions, we are highly optimistic we will get clearance by the latter part of June 2024.
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 demands and be able to reach and address a large percentage of the patient population who continue to struggle with CPAP compliance.
Forward-looking Statements.
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)
Contact:
REMSleep Holdings, Inc.
14175 ICOT Blvd
Suite 300
Clearwater, FL 33760
Email:twood@remsleep.com
Phone: 912-590-2001
Fax: 813-639-7501
