FDA Registered

The Lotus Seat with PureStream is registered with the Food & Drug Administration (FDA) #3005596594 under Medical Specialty: Physical Medicine, Regulation Number 890.5050, Device Class 1, Product Code ILS, Classification Name: Adaptor-Hygiene, Common Name Toilet Seat-Bidet.

It is identified as a 'daily activity assist device' that is intended for medical purposes to assist a patient in performing a specific function.

Please visit the link below on the FDA website for additional information.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/search/search.cfm?db=LST&ID=96706

Listing of Lotus Product on FDA's database.