Regulatory Information

detrusan® is manufactured in compliance with International Standards (ISO) and has been approved in Europe and the US under the following regulations:.

FDA 510K code K994109

Declaration of Conformity: Medical Device Class II; Medical Device Directive 93/42 EWG, annex VII.

Manufactured according EN 60601.

Treatment for Incontinence

Urinary incontinence (UI) can be treated using medical and non-medical methods. Medical treatments can range from medication to surgery.

Why detrusan®

detrusan® has been designed to take advantage of decades of clinical research. It incorporates a wide variety of stimulation protocols that have been optimized for specific conditions