# K990041: Urostym Biofeedback and Stimulation Probes

- Pathway: 510(k) (Traditional)
- Applicant: Laborie Medical Tech Corp.
- Decided: Aug 5, 1999 after 211 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The UROSTYM™ biofeedback and stimulation probes are used in treating urinary incontinence by pelvic re-education and stimulation. The UROSTYM™ non-implanted electrical stimulator is applied to the pelvic floor musculature and surrounding structures in the treatment of incontinence. The probes provide low-intensity electrical stimulation to the pelvic floor muscles.

Source page: https://510kreport.com/device/K990041
Methodology: https://510kreport.com/methodology