REMSleep Holdings Inc. Receives 510(K) Clearance on Product

Rhea-AI Summary

REMSleep Holdings announced that it received 510(K) clearance for its new Deltawave CPAP Pillows Interface mask. The clearance allows the device to be marketed under the regulations set by the FDA. This product is classified as a Class II noncontinuous ventilator and meets the necessary regulatory requirements. With this approval, REMSleep plans to prepare the Deltawave CPAP interface for market launch by updating its website, ordering inventory, and corresponding with distributors. The company also identified notable short interest and possible illegal naked short sales, committing to legal actions to protect shareholder interests.

Positive

• Received 510(K) clearance for the Deltawave CPAP Pillows Interface mask, allowing marketing under FDA regulations.
• Plans to prepare for market launch, including updating the website, ordering inventory, and engaging with distributors.

Negative

• Reported significant short interest and potential illegal naked short sales.

CLEARWATER, Fla., July 09, 2024 (GLOBE NEWSWIRE) -- REMSleep Holdings, Inc. (OTCQB: RMSL) announces the company has been awarded 510(K) Clearance for the new Deltawave CPAP Pillows Interface mask. The company would like to share the following correspondence with its shareholders:

Re: K233415
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

Dear Judy Strzepek:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

Now that REMSleep has received 510(K) clearance, the company will begin preparing the Deltawave CPAP interface for market. This preparation includes updating the website, ordering large inventory, corresponding with potential distributors, and handling all other marketing areas. The greatest marketing impact for Deltawave will come from its exceptional performance.

REMSleep has identified imbalances and reported short interest, indicating the potential presence of illegal naked short sales. These imbalances are significantly notable. The company will continue to monitor these activities and is committed to taking all necessary legal actions to protect its shareholders' interests and combat potential manipulative trading activities, ensuring fair market conditions.

We encourage our shareholders to stay up to date by following the company’s press releases and social media outlets.

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.

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

IR Contact:
Preya Narain
Info@preya.co
https://www.preya.co/

FAQ

What is the recent development announced by REMSleep Holdings?

REMSleep Holdings announced that it received 510(K) clearance for its new Deltawave CPAP Pillows Interface mask.

When did REMSleep Holdings receive the 510(K) clearance for its new product?

REMSleep Holdings received the 510(K) clearance on October 4, 2023.

What is the significance of 510(K) clearance for REMSleep Holdings?

The 510(K) clearance allows REMSleep Holdings to market its Deltawave CPAP Pillows Interface mask under FDA regulations.

What are REMSleep Holdings' plans after receiving the 510(K) clearance?

REMSleep Holdings plans to update its website, order large inventory, correspond with potential distributors, and handle other marketing areas to prepare for the market launch.

What regulatory classification does the Deltawave CPAP Pillows Interface mask fall under?

The Deltawave CPAP Pillows Interface mask is classified as a Class II noncontinuous ventilator.

What issues has REMSleep Holdings identified concerning its stock?

REMSleep Holdings has identified significant short interest and potential illegal naked short sales.

What actions will REMSleep Holdings take regarding the identified stock issues?

REMSleep Holdings is committed to taking all necessary legal actions to protect shareholders' interests and combat potential manipulative trading activities.