# K093600: Omnistim Continence+ Pelvic Floor Stimulation System

- Pathway: 510(k) (Traditional)
- Applicant: Accelerated Care Plus
- Decided: Dec 4, 2009 after 14 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
A non-implanted electrical stimulator for urinary incontinence is intended to retrain the urinary continence mechanisms by way of electrical stimulation applied to the pelvic floor musculature and surrounding structures. Typically, these devices are indicated for use in females for treatment of stress incontinence, urge incontinence, or mixed incontinence (a combination of stress and urge incontinence). Intended for use in acute and ongoing treatment of urinary incontinence in cases where the following results may improve urinary control: Improvement of urethral sphincter closure, strengthening of pelvic floor muscles, Inhibition of the detrusor muscle through reflexive mechanisms.

Source page: https://510kreport.com/device/K093600
Methodology: https://510kreport.com/methodology