Vad betyder "Godkänd av FDA"?
Postat: ons 03 jun 2020, 11:53
se: https://quackwatch.org/device/reg/510k/
Kort sagt: Var väldigt skeptisk då du hör att någon manick är "godkänd av FDA"Misrepresentations
Unfortunately, some manufacturers have obtained FDA clearance without revealing the actual use of the device. For example:
“Electrodermal skin testing” devices used to diagnose and/or treat the gamut of disease have been cleared because their manufacturers told the FDA they were biofeedback devices that (merely) measure the electrical resistance of the skin. The applications did not disclose that the devices are sold with software that contains diagnostic or therapeutic advice .