RemSleep Holdings Inc (RMSL)

[James salmon]

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 time led RemSleep to change its 510k consultant and hire the current one who substantially altered the testing and administration protocol to address issues identified by the reviewer. The proposed regimen was further influenced by her extensive experience in regulatory review with respiratory masks. The current FDA reviewer is the same individual who was assigned to the previous submission.