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RemSleep Holdings Inc. Announces Submission of DeltaWave Mask for FDA 510K Review
RemSleep Holdings Inc. Announces Submission of DeltaWave Mask for FDA 510K Review.
About this update from Remsleep Holdings, Inc.
[{"type":"text","content":"TAMPA, FL / ACCESSWIRE / 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 510K Review. The company invites investors to review the submission process timeline by the FDA at the following link: https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process#timeline. A summary graphic of the review process is included below: RemSleep CEO, Tom Wood, commented: "It is with excitement and relief that we can finally share this with our investors and definitively move forward with the DeltaWave. As we've said before, we have certainly had our share of setbacks but, throughout the process, we have been compelled by our confidence in the DeltaWave both in its safety, and its superior performance relative to traditional masks on the market. Further, with the guidance and expertise from our Senior Director for Regulatory Compliance, Judy Strzepek, we are confident we have provided all and any information the FDA will need for its substantive review. While we cannot anticipate every area the FDA might have further questions, her past regulatory experience was pertinent in designing the testing protocol for the DeltaWave to help mitigate the need for additional information requests. As always, we thank our investors for their patience and confidence in RemSleep."During the review process, the company will continue to focus on the business objectives outlined previously in its shareholder letter including: aligning with distributors and partners for post clearance sales and marketing, CPAP and related equipment sales and marketing in conjunction with the DeltaWave, and continued development of the next generation DeltaWave masks.RemSleep will continue to update investors as information becomes available and will be confirmed on the company website: www.remsleep.com, and through the company Twitter feed: @RemsleepInc.About RemSleep Holdings Inc.RemSleep Holdings Inc. is a medical d...