False. You obviously haven't read their PRs or filings since 2015. They claimed they had filed the 510k and were waiting for FDA approval when they took over the RMSL shell from KAT Gold at the end of 2014.
They have been claiming it was forthcoming for years and then finally admitted it was rejected and resubmitted recently.
So you are saying that despite issuing a press release in August 2017 that the DeltaWave was available for pre-order with delivery in November 2017 that they hadn't submitted the 510k application to the FDA until last year? Ok.
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