Implanted Electrical Device Intended for Treatment of Fecal Incontinence

What Is This Device?

Treatment of chronic fecal incontinence

How Is QON Classified?

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence is FDA product code QON, Class 3, 21 CFR 876.5270.

How Does It Reach the US Market?

A premarket approval is required: the Class 3 route, granted on clinical evidence rather than on equivalence to an existing device. No approval under this code names a Chinese applicant.