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 Zmi Electronics , Ltd., Easymed Instruments Co., Ltd. and Verity Medical , Ltd..
FDA 510(k) Cleared Stimulator, Electrical, Non-implantable, For Incontinence Devices (Product Code KPI)
About Product Code KPI - Regulatory Context
510(k) Submission Activity
93 total 510(k) submissions under product code KPI since 1976, with 93 receiving FDA clearance (average review time: 174 days).
Submission volume has increased in recent years - 9 submissions in the last 24 months compared to 7 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under KPI have taken an average of 226 days to reach a decision - up from 169 days historically. Manufacturers should account for longer review timelines in current project planning.
KPI devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →