RemSleep applications advances
By HME News Staff
Updated 10:33 AM CDT, Tue May 10, 2022
TAMPA, Fla. – RemSleep Holdings says it has responded to the Additional Information request related to its 510(k) application to the U.S. Food and Drug Administration for its patented DeltaWave nasal mask CPAP interface. “This submission is expected to be the final step and pivotal moment for our company,” said CEO Tom Wood. “It will dramatically strengthen the commercialization of our brand and make the DeltaWave a premier product that reinforces our commitment to providing accessible, comfortable and quality care for so many who seek treatment for sleep apnea.” RemSleep anticipates receiving a decision from the FDA in about 30 days. In March, the company announced that it had engaged a new third-party lab to redo testing for the DeltaWave as part of the 510(k) process.
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