Wellness Device vs. Medical Device

A regulatory classification that determines how a PEMF device can be marketed and what claims it may make. Wellness devices are intended for general wellness support (relaxation, recovery, circulation) and can't claim to diagnose, treat, cure, or prevent specific diseases. Medical devices undergo additional regulatory review (such as FDA clearance or approval) and may make specific therapeutic claims for named conditions. The distinction affects labeling, advertising, and the clinical settings in which a device may be used.