# K142369: Urinary Incontinence System

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Finecure Medical Equipment Co.,Ltd
- Decided: Jun 17, 2015 after 296 days
- Product code: KPI (Stimulator, Electrical, Non-Implantable, For Incontinence)
- Device class: 2
- Regulation: 21 CFR 876.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K930530 (1995). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110179: Incontrol, Incontrol Medical, LLC (2012) Summary page 5.
- K103698: Tenscare Itouch Sure Model Its, Tenscare, Ltd. (2011) Summary page 5.

## Indications for use
The Urinary Incontinence System with various treatment modalities is intended to be used by males and females for muscle contraction in the treatment of stress incontinence, urge incontinence, and mixed incontinence.

Source page: https://510kreport.com/device/K142369
Methodology: https://510kreport.com/methodology