# K070331: Urostym Biofeedback and Stimulation Device and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Laborie Medical Technologies
- Decided: May 4, 2007 after 88 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 TnBiofeedback and Stimulation Device is used for treating urinary incontinence by way of perineal re-education. The Urostym probes are non-implanted electrical devices applied to the pelvic floor musculature and surrounding structures for therapy in the treatment of urinary incontinence. The probes and patches are provided non-sterile for single (individual) patient use / disposable. The probes are for office or hospital use under the direction of a physician or other licensed healthcare professional.

Source page: https://510kreport.com/device/K070331
Methodology: https://510kreport.com/methodology