FOOD & DRUG ADMINISTRATION

FDA Registration or Approval is not required

• Lifewave markets X39 as a “general wellness” product—low-risk, non-transdermal patches intended to support health and vitality, without claiming to diagnose, treat, cure, or prevent any disease.

 

• The FDA generally does not regulate low-risk wellness products the same way it does medical devices, so these products often escape stringent oversight and don’t appear on the FDA’s Establishment Registration & Device Listing.