false 0001412126 0001412126 2024-07-02 2024-07-02 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): July 2, 2024

 

REMSLEEP HOLDINGS, INC.

(Exact Name of Registrant as Specified in Charter)

 

Nevada   000-53450   47-5386867

(State or Other Jurisdiction

of Incorporation)

  (Commission File Number)  

(IRS Employer

Identification No.)

 

14175 Icot Boulevard, Suite 300

Clearwater, Florida 33760

(Address of Principal Executive Offices)

 

Registrant’s telephone number, including area code: 912-590-2001

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
None   N/A   N/A

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

Item 8.01 Other Events

Press Release

 

On July 2, 2024 Remsleep Holdings, Inc (the “Company”) provided a press release accounting that it had been awarded 510(k) Clearance by the Food and Drug Administration for its Deltawave CPAP Pillows Interface Mask. A full copy of the press release is included as Exhibit 8.1

 

(d)       Exhibits.

 

Exhibit No.   Description
8.1   Press Release dated July 2, 2024.

 

 

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: 10 July, 2024 REMSLEEP HOLDINGS, INC.
     
  BY: /S/ THOMAS J. WOOD
    Thomas J. Wood,
    Chief Executive Officer

 

 

 

 

 

 

Exhibit 8.1

 

EXHIBIT 8.1 TEXT OF PRESS RELEASE

 

EQS-News: REMSleep 510(K) SubmissionPress Release | 07/02/2024

EQS-News: Remsleep Holdings / Key word(s): Financial
REMSleep 510(K) Submission

03.07.2024 / 00:20 CET/CEST
The issuer is solely responsible for the content of this announcement.

CLEARWATER, FL - (NewMediaWire) - July 2, 2024 - REMSleep Holdings, Inc. (OTCQB: RMSL) announces the company has been awarded 510(K) Clearance for the new Deltawave CPAP Pillows Interface mask.
 

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"

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 Companys future prospects and risks in investing in Companys 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

v3.24.2
Cover
Jul. 02, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Jul. 02, 2024
Entity File Number 000-53450
Entity Registrant Name REMSLEEP HOLDINGS, INC.
Entity Central Index Key 0001412126
Entity Tax Identification Number 47-5386867
Entity Incorporation, State or Country Code NV
Entity Address, Address Line One 14175 Icot Boulevard
Entity Address, Address Line Two Suite 300
Entity Address, City or Town Clearwater
Entity Address, State or Province FL
Entity Address, Postal Zip Code 33760
City Area Code 912
Local Phone Number 590-2001
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Emerging Growth Company false

RemSleep (QB) (USOTC:RMSL)
Historical Stock Chart
Von Nov 2024 bis Dez 2024 Click Here for more RemSleep (QB) Charts.
RemSleep (QB) (USOTC:RMSL)
Historical Stock Chart
Von Dez 2023 bis Dez 2024 Click Here for more RemSleep (QB) Charts.