Enema Kits and Enema Bags
Enema Kits - Combinations of components sold for use as an enema.
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.
Manufacturing Requirements: Enema Kits do not require specific FDA approval and can be manufactured by many companies.
Retail Requirements: Many companies sell enema kits. In the past, they were sold by most retail pharmacies. They have become hard to find in your neighborhood drugstore, but online retailers of enema products exist. Try EnemaSupply.com or EnemaEquipment.com for products like the one above.
Reference: FDA.gov