In order for medical devices to be legally marketed (sold) in the United States, they are required to be cleared or approved by the FDA unless it is 510(k) exempt. Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to (similar) another legally marketed device.  They undergo strict guidelines for manufacturing and material use.  VitalSleep contains FDA-approved materials. 

Avoid mouthpieces that are not FDA-cleared such many as low cost made in China products. 

Did this answer your question?