CEO didn't file a PMA until 2021 which is why it's been seven years with no cleared 510k and the company diluted into the ground.
He didn't disclose he was trying to pass off the 2008 510k from the Laminair modified as the DeltaWave when any fool could see they look nothing alike and no way in hell passable with the FDA.
PMA is a much more in depth process. Shortcut and non-disclosure cost folks a lot of time and money.
If you claim to have been doing it for years you know that the fda 510k has set time limits. There is no scenario that a 510k takes longer then a year without needing to be refilled
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