# K970077: Liberty Plus System (PFS-300)/Vaginal Probe, Liberty Plus (PFS-044)

- Pathway: 510(k) (Traditional)
- Applicant: Utah Medical Products, Inc.
- Decided: May 23, 1997 after 134 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: 2 generations back to K891773 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960496: Liberty Lite PFS System, Utah Medical Products, Inc. (1996) Summary page 1.
- K945611: Peritron, Cardio Design Pty., Ltd. (1996) Summary page 1.

## Indications for use
This device is intended as therapeutic aid in the conservative treatment of stress incontinence, urge incontinence or mixed stress and urge incontinence in women. Patients appropriate for this therapy should be selected using the following criteria: Indications: • Good general health, both mentally and physically. • Urge incontinence due to detrusor instability or of idiopathic origin. • Stress incontinence not associated with intrinsic sphincter deficiency. • Mixed incontinence. • Ability of patient to understand and demonstrate understanding of the use of the Liberty Plus System. • Willingness to comply with the therapy plan. Contraindications: • Use of a cardiac pacemaker, or a history of rate or conductive disturbances. • Neurological deficiency that would not permit proper sensory perception or stimulation. • Currently pregnant or attempting to get pregnant. • Anatomical vaginal structure that does not permit proper and complete placement of the vaginal probe. • Irregular menstrual bleeding cycles. • Any urinary or vaginal infections, localized lesions or other undiagnosed symptoms. • History of urinary retention or current symptoms.

Source page: https://510kreport.com/device/K970077
Methodology: https://510kreport.com/methodology