Identifiers
- 510(k) Number
- K960496 FDA 510(k)
- FDA Product Code
- KPI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5320 FDA 510(k)
- Regulation Number
- 876.5320 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Liberty Lite Pfs System is an Electrical Stimulator, Non-Implantable, For Incontinence. It is designed to treat urinary incontinence through electrostimulation of the pelvic floor nerve and muscle tissues. The system consists of a tampon-shaped device that is placed in either the vagina or rectum. The device is used for pelvic floor stimulation therapy, which activates natural nerve and muscle mechanisms to treat stress, urge, and mixed urinary incontinence.
The Liberty Lite Pfs System is supplied as a non-invasive treatment and is regulated under the product code KPI. It has been cleared by the FDA under the traditional clearance type with the regulation number 876.5320. The system is intended for use in the treatment of urinary incontinence and is available with the authorization FDA 510K.
Frequently asked questions
What is the Liberty Lite PFS System used for?
The Liberty Lite PFS System is used for pelvic floor stimulation therapy to treat stress, urge, and mixed urinary incontinence by electrostimulating the pelvic floor nerve and muscle tissues.
How is the Liberty Lite PFS System supplied?
The Liberty Lite PFS System is supplied as a non-invasive treatment, consisting of a tampon-shaped device that is placed in either the vagina or rectum.
Is the Liberty Lite PFS System regulated?
The Liberty Lite PFS System is regulated under the product code KPI and has been cleared by the FDA under the traditional clearance type with the regulation number 876.5320.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Pelvic Floor Stimulation for Urinary Incontinence - Liberty, PDF Liberty Pelvic Floor Stimulation - utahmedicalproducts.com, Liberty | Designer Department Store Selling Luxury Brands, Pelvic Floor Stimulation (PFS) for Urinary Incontinence - Utah Med
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K960496 | Class II | Active |
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Manufacturer
- Manufacturer
- Utah Medical Products, Inc.
Sources (1)
- FDA 510(k) K960496 24 fields · synced Oct 6, 2026