Tag: DeltaWave
RemSleep crosses milestone
September 5, 2023HME News Staff
TAMPA, Fla. – RemSleep has successfully passed testing protocol for 510K clearance of its DeltaWave CPAP mask, including cytotoxity and MLA tests, which were the subject of past issues requiring retesting. The company now expects submit for 510k clearance with the U.S. Food and Drug Administration before the end of September. "This is a substantial and critical milestone for RemSleep and the DeltaWave mask,” said CEO Tom Wood. “It has taken significantly longer to get to this point...
RemSleep applications advances
May 10, 2022HME News Staff
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...
REMSleep provides update on DeltaWave
March 29, 2022HME News Staff
TAMPA, Fla. – REMSleep has engaged a new third-party lab to redo testing for its DeltaWave as part of the 510k process for the nasal CPAP interface. The company says it has received a negative result on a cytotoxicity test due to incorrect procedures performed by a previous lab and has failed a re-test due to a faulty analysis by a testing company. “The failed test is not a result of management; we have run into a problem that we had not anticipated,” said CEO Tom Wood. “While...