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REMSleep 510K Submission

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REMSleep Holdings, Inc. (OTC PINK: RMSL) announced that the FDA requires additional testing for its 510K submission regarding product development. The company plans to initiate testing promptly. Furthermore, proceeds from the Reg A offering will support ongoing product development, expected patent applications, and inventory buildup pending 510K approval. The press release also contains forward-looking statements highlighting risks, including the potential inability to secure financing and regulatory challenges that could affect business outcomes.

Positive
  • Proceeds from the Reg A offering will be used for product development and marketing.
  • The company is actively pursuing additional testing for FDA approval, indicating commitment to compliance.
Negative
  • FDA requires additional testing for the 510K submission, delaying the approval process.
  • Potential risks include the inability to secure necessary financing, impacting future business operations.

Condensation testing per ISO 18562-4 :2017

Tampa, FL, Oct. 28, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- REMSleep Holdings, Inc. (OTC PINK: RMSL): The company has been advised by the FDA after considerable correspondence that additional testing is required for its 510K submission.  Remsleep is proceeding with the testing as soon as possible.

Proceeds from Reg A will be used for additional product development, expected new patent application(s), aggressive marketing, product inventory after 510K approval.

Forward-looking statements.

Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company's ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company's business plan; competition; regulation and anticipated and unanticipated costs and delays, and other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities. No information in this press release should be construed as any indication whatsoever of the Company's future revenues, results of operations or stock price. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.

Tom Wood
twood@remsleep.com


FAQ

What does the FDA require from REMSleep Holdings for its 510K submission?

The FDA requires additional testing for the 510K submission from REMSleep Holdings.

How will REMSleep Holdings use the proceeds from the Reg A offering?

Proceeds will support product development, new patent applications, and inventory build-up after 510K approval.

What are the potential risks mentioned in REMSleep Holdings' press release?

Potential risks include inability to secure financing and regulatory challenges that could affect business outcomes.

What is the stock symbol for REMSleep Holdings?

The stock symbol for REMSleep Holdings is RMSL.

REMSLEEP HOLDINGS INC

OTC:RMSL

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