FWIW the EU also has EUDAMED registry for producers, distributors and importers of medical devices and there are additional regulations beyond CE under the MDR

FWIW the EU also has EUDAMED registry for producers, distributors and importers of medical devices and there are additional regulations beyond CE under the MDR directive. I don't see "ZenBud" or "NeurGear" in the EUDAMED database. An ultrasonic device delivering energy to human tissue would be a class 2a or 2b active medical device under MDR.