RMSL

REMSleep Holdings, Inc. Announces Distributor Request for DELTAWAVE Nasal Pillows System Samples

Jul 24, 2024

Clearwater, FL, July 24, 2024 - REMSleep Holdings, Inc. (OTCQB: RMSL), a leader in innovative sleep apnea products, is thrilled to announce that a significant distributor in the CPAP industry has requested samples of its new nasal interface, the DELTAWAVE Nasal Pillows System. This request marks a pivotal step in REMSleep's mission to revolutionize sleep apnea treatment with cutting-edge technology and superior comfort. REMSleep is currently in the process of preparing the DELTAWAVE Nasal...

REMSleep Holdings Inc. Announces Strategic Marketing Plan for DELTAWAVE Nasal Pillows System

Jul 17, 2024

Clearwater, FL, July 17, 2024– REMSleep Holdings Inc. (OTCQB: RMSL), a pioneer in sleep apnea treatment solutions, is thrilled to announce a comprehensive marketing strategy for its revolutionary DELTAWAVE Nasal Pillows System. This strategic plan aims to significantly expand the market presence of DELTAWAVE by identifying and partnering with key distributors nationwide The DELTAWAVE Nasal Pillows System, designed with cutting-edge technology, offers an innovative solution for those suffering...

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

Jul 9, 2024

CLEARWATER, FL, July 9, 2024 - 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: K233415Trade/Device Name: DELTAWAVE Nasal Pillows SystemRegulation Number: 21 CFR 868.5905Regulation Name: Noncontinuous Ventilator (IPPB)Regulatory Class: Class IIProduct Code: BZDDated: October 4, 2023Received: October 10, 2023 Dear...

Remsleep Holdings Inc.’s DeltaWave Mask has received questions from FDA regarding 510k submission (K233415)

Jan 22, 2024

Tampa, FL, January 22, 2024 - RemSleep Holdings Inc. (OTCQB: RMSL), a medical device manufacturer dedicated to forever changing the level of treatment provided to Obstructive Sleep Apnea (OSA) has received a response to the company’s 510(K) submission K233415. The agency has determined that additional information is required. The agency has asked for additional information regarding Administrative Information, Device Description, Substantial Equivalence (SE), Labeling, Biocompatibility, and...

Remsleep Holdings Inc.’s DeltaWave Mask Moves to Substantive Review of FDA 510k Process

Nov 2, 2023

Tampa, FL, November 2, 2023 - RemSleep Holdings Inc. (OTCQB: RMSL), a medical device manufacturer dedicated to forever changing the level of treatment provided to Obstructive Sleep Apnea (OSA) patients, is pleased to announce its DeltaWave mask has moved to the Substantive Review portion of the FDA 510k review process. Previously, the company voluntarily withdrew its 510k submission during the Acceptance Review portion after meeting with the FDA reviewer. The comments from the reviewer at the...

RemSleep Holdings Inc. Announces Submission of DeltaWave Mask for FDA 510K Review

Oct 6, 2023

Tampa, FL, October 6, 2023 - RemSleep Holdings Inc. (OTCQB: RMSL), a medical device manufacturer dedicated to forever changing the level of treatment provided to Obstructive Sleep Apnea (OSA) patients, announces it has submitted the DeltaWave mask to the FDA for 510K review. After a series of unfortunate and frustrating delays due to Covid, industry recalls, and 3rd party testing that required retesting certain tests, RemSleep is excited to announce it has submitted the DeltaWave mask for FDA...

RemSleep Holdings Inc. Provides an Update on Funding and DeltaWave

Sep 25, 2023

Tampa, FL, September 25, 2023 - RemSleep Holdings Inc. (OTCQB: RMSL), a medical device manufacturer dedicated to forever changing the level of treatment provided to Obstructive Sleep Apnea (OSA) patients, announces a new investor agreement and DeltaWave submission update. RemSleep recently entered into a Purchase Agreement with Janbella Group, LLC which was the subject of an 8K filling dated September 18th and will commence with the registration statement on Form S-1 to be filed by...

RemSleep Holdings Inc. Announces Completion of DeltaWave CPAP Mask Testing

Sep 1, 2023

Tampa, FL, September 1, 2023 - RemSleep Holdings Inc. (OTCQB: RMSL), a medical device manufacturer dedicated to forever changing the level of treatment provided to Obstructive Sleep Apnea (OSA) patients, provides an update on its testing protocol for 510K clearance of its DeltaWave CPAP Mask. RemSleep has completed the testing protocol for 510K clearance and all tests have successfully passed including the Cytotoxicity and MLA tests which were the subject of past issues requiring retesting....

NEWSROOM

REMSleep Holdings, Inc. Announces Distributor Request for DELTAWAVE Nasal Pillows System Samples

REMSleep Holdings Inc. Announces Strategic Marketing Plan for DELTAWAVE Nasal Pillows System

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

Remsleep Holdings Inc.’s DeltaWave Mask has received questions from FDA regarding 510k submission (K233415)

Remsleep Holdings Inc.’s DeltaWave Mask Moves to Substantive Review of FDA 510k Process

RemSleep Holdings Inc. Announces Submission of DeltaWave Mask for FDA 510K Review

RemSleep Holdings Inc. Provides an Update on Funding and DeltaWave

RemSleep Holdings Inc. Announces Completion of DeltaWave CPAP Mask Testing

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