EnemaEquipment.org

Enema Nozzles and TIps - Enema nozzles and tips are enema equipment that is more formally tracked by the FDA.  A recent meeting our company had with the FDA suggests that enema nozzles with only a hole on the tip are exempt from FDA pre-market notification (see the kit above for this type of enema nozzle) while enema nozzles with holes along the side are required to be registered with the FDA.  Inflatable enema nozzles are a separate category altogether.  These items are covered on a separate page of this website.  

Legal Classification:  A Class 1 Medical Device with a 501k requirement.  Here is a little more information about what information has to be registered before an enema nozzle can be brought to market.  

Manufacturing Requirements:  Enema nozzles are manufactured by companies that are registered with the FDA.  If you wish to manufacture enema nozzles or import enema nozzles for sale in the USA you must fill out and have your 501k documents approved.  Unapproved or unregistered product are not legal for sale in the USA.

Retailing Enema Nozzles:  Enema nozzles must be sold in their original packaging.  Buying enema nozzles in bulk and reselling them is illegal as it removes the consumers ability to understand the origin of the device they have purchased.  Any company that repackages medical devices in this manner becomes the de facto manufacturer of the products and must assume the responsibility of an equipment manufacturer.  If conumers purchase an enema nozzle or enema tip from a retailer and it is packaged loosely, they should  consider returning the device.  Product shipped without the manufacturers packaging may not carry any liability insurance and may not have been reviewed by the FDA for safety purposes.  Some retailers also remove the packaging from merchandise because it carries a prescription warning.  If you receive a device with the note:  "To be used under the order of a physician" this is a prescription item and not legal for retail sale online.  These items are illegal for retail sale and are illegal to own without a prescription from a licensed physician.  

Note:  In 2004 EnemaSupply.com was investigated by the FDA.  After the investigation concluded their selection of merchandise was changed to reflect only legal merchandise.  They negotiated a settlement that kept their client data confidential but paid a substantial fine to the FDA.