The "orders" are for third party cpap machines. They can't sell the DeltaWave until the 510k is cleared by the FDA. The company is currently valued at over $50 million dollars which is ABSURD when the same third party cpap machines are a dime a dozen all over the internet.
They failed two cytotoxicity tests and the communication regarding disclosure didn't occur until a year after the test failed and it also recently failed the retest: