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I'm skeptical of these devices that say they are safe based on CE or FCC testing. (zenbud says it has been CE tested). That's consumer product testing, not hea
by ajb 1y ago
I'm skeptical of these devices that say they are safe based on CE or FCC testing. (zenbud says it has been CE tested). That's consumer product testing, not health-device testing; I would like to see some evidence that long-term use of a nerve stimulation device causes no long term damage. I don't believe that CE or FCC tests show that. It's disingenuous to have a press release saying "Yay! We passed CE testing!" as if that was like FDA approval.
- deno 1y agoFWIW 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.