Shower Enemas - Shower Shot Enemas
Shower Enema Kits - The FDA makes no mention of the water source for an enema kit in their regulation. Currently, shower powered enema kits like this are on the market and being sold as exempt products. Legal Classification: A Class 1 (exempt) 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. They are exempt from any pre-market registration. Currently, the FDA is not interested in the source of water for an enema kit or what the source pressure of that water may be. This is probably largely a result of the fact that very few products of this type exist. If injuries do occur that are related to water pressure, we suspect that the FDA would become very interested in regulating these items. Manufacturing Requirements: Enema Kits do not require specific FDA approval and can be manufactured by many companies. Companies that make shower enemas tend to be small and specialized. If some regulation was introduced, we expect it would put all of them out of business. Retail Requirements: Shower enema kits are hard to find. Only a few online retailers stock them. Try EnemaSupply.com or EnemaEquipment.com for them. Reference: FDA.gov