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 Everyway Medical Instruments Co.,Ltd, Well-Life Healthcare Limited and BTL Industries, Inc..
List of Stimulator, Electrical, Non-implantable, For Incontinence devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Stimulator, Electrical, Non-implantable, For Incontinence devices (product code KPI). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Gastroenterology & Urology FDA review panel. Browse all Gastroenterology & Urology devices →