FDA Product Code KPI: Stimulator, Electrical, Non-implantable, For Incontinence

Bladder control problems affect millions of patients and can be treated non-invasively. FDA product code KPI covers non-implantable electrical stimulators for the treatment of urinary incontinence.

These devices deliver electrical impulses to the pelvic floor muscles or sacral nerve roots to strengthen urinary sphincter control, reduce detrusor overactivity, and improve bladder capacity in patients with stress, urge, or mixed urinary incontinence.

KPI devices are Class II medical devices, regulated under 21 CFR 876.5320 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include Hollister, Inc., Empi and Incontrol Medical, LLC.