Imported Enema Bags and Enema Kits
Imported Enema Kits - Combinations of components sold for use as an enema that are made outside of the USA. Legal Classification: A Class 1 Medical Device. Class 1 Medical devices like enema kits are legal for over-the-counter sales and for home use without the aid of a physician. Regardless of where these products are made, they are still classified in the same manner. Manufacturer/Importer Requirements: Enema Kits do not require specific FDA approval and can be manufactured and imported by many companies. Retail Requirements: Enema products are more popular in other countries where regular enema use is still commonplace. For this reason, companies import product for select use in the USA. Try EnemaSupply.com or EnemaEquipment.com for products like the one above. Reference: FDA.gov