CPAP, BiPAP, and ASV machines, along with their associated masks and humidifiers, are classified as Class II medical devices by the FDA. As such, a valid prescription is required for the legal sale of these devices.
However, prescriptions are not necessary for other PAP accessories, including filters, mask components, tubing, and other external parts.
When ordering from Sleep Doctor, you will be informed whether a prescription is required for each specific item.
To view further information about the Federal regulations, please visit the American Academy of Sleep Medicine website or the federalregister.gov.