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Liberty

FDA UDI

Class II (US FDA UDI)

by Utah Medical Products, Inc.

Identity

Trade Name
LIBERTY FDA UDI
Generic Name
Perineal orifice incontinence-control electrical stimulation system generator FDA UDI
Device Name
Pelvic Floor Execiser System, Stimulator Unit, For use with Liberty execiser probes only, Includes Carrying Case, Batteries, and Instructional DVD FDA UDI
Model / Reference
Stimulator FDA UDI
Description
Pelvic Floor Execiser System, Stimulator Unit, For use with Liberty execiser probes only, Includes Carrying Case, Batteries, and Instructional DVD FDA UDI

Identifiers

Catalog Number
PFS-200 FDA UDI
Primary DI / UDI-DI
H671PFS2000 FDA UDI
510(k) Number
K960496 FDA UDI
FDA Product Code
KPI FDA UDI
GMDN Term
Perineal orifice incontinence-control electrical stimulation system generator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5320 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Perineal orifice incontinence-control electrical stimulation system generator

Liberty by Utah Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K960496 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Utah Medical Products, Inc.

Sources (1)

  • FDA UDI d303ed12-a9c1-47bf-ab50-21b5fdad8807 37 fields · synced Jun 9, 2026