← Product Code [KPI](/productcode/KPI) · K964526

# LIBERTY RECTAL PELVIC FLOOR EXERCISER (K964526)

_Utah Medical Products, Inc. · KPI · Feb 10, 1997 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K964526

## Device Facts

- **Applicant:** Utah Medical Products, Inc.
- **Product Code:** [KPI](/productcode/KPI.md)
- **Decision Date:** Feb 10, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5320
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
- **Attributes:** Therapeutic

## Indications for Use

The PFS-043 is indicated for use to help train the pelvic floor muscles using electrical stimulation. The PFS-043 is a rectal applicator that is used with the UMP Liberty PFS System (PFS), which is a battery powered electrostimulation device that applies electrical stimulation through electrodes on the applicator.

## Device Story

Rectal applicator for pelvic floor neuromuscular training; used with Liberty PFS battery-powered electrostimulation device. Device consists of injection-molded thermoplastic body with two stainless steel electrode rings. Conducts electrical energy via two-conductor cable/connector to stimulator. Used by patients to train pelvic floor muscles for urinary continence improvement. Healthcare provider oversees therapy; device provides electrical stimulation to neuromuscular tissue.

## Clinical Evidence

Bench testing only. Laboratory tests demonstrated equivalent electrical stimulation of pelvic floor muscles compared to the predicate ICAA applicator.

## Technological Characteristics

Injection-molded thermoplastic applicator; two stainless steel electrode rings; two-conductor cable/connector interface. Energy source: external battery-powered stimulator. Biocompatible materials. Non-implanted device.

## Regulatory Identification

A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).

## Predicate Devices

- UMP Liberty Probe (PFS-041) ([K960496](/device/K960496.md))
- Hollister InCare Anal Applicator (ICAA) ([K891773](/device/K891773.md))

## Submission Summary (Full Text)

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K964526

UTAH MEDICAL PRODUCTS INC.

FEB 10 1997

510(k) Summary

November 8, 1996

![img-0.jpeg](img-0.jpeg)

Trade Name: Liberty Rectal Pelvic Floor Exerciser
Common Name: Electrical Pelvic Floor Stimulation System
Classification: Nonimplanted Electrical Continence Device. 21 CFR §876.5320

The Utah Medical Products, Inc. (UMP) Liberty Rectal Pelvic Floor Exerciser (PFS-043) is substantially equivalent to the UMP Liberty Probe (PFS-041), cleared for marketing under K960496, and to the Hollister InCare Anal Applicator (ICAA), cleared for marketing under K891773.

The device consists of an injection molded thermoplastic applicator that supports two stainless steel electrode rings that apply electrical stimulation to a patient in order to help train neuromuscular tissue in the pelvic floor for improvement or restoration of urinary continence in men and women. The electrical stimulation energy is conducted to the electrodes via a two conductor cable and connector that plugs into the Liberty Stimulator.

The PFS-043 is indicated for use to help train the pelvic floor muscles using electrical stimulation. The PFS-043 is a rectal applicator that is used with the UMP Liberty PFS System (PFS), which is a battery powered electrostimulation device that applies electrical stimulation through electrodes on the applicator.

The technological characteristics of the UMP PFS-043 probe are substantially equivalent to the UMP PFS-041 probe and the ICAA applicator. There are differences in the size and placement of the stainless steel electrodes and in the thermoplastic materials used to mold the applicators, however, the PFS-043 probe and the ICAA applicator both utilize a single electrode pair with equivalent anatomical placement. The new device and the predicate devices are all manufactured using biocompatible materials.

Laboratory tests of the UMP PFS-043 probe and the ICAA applicator demonstrated that they provide equivalent electrical stimulation of the pelvic floor muscles.

![img-1.jpeg](img-1.jpeg)

Kevin L. Cornwell
President & CEO

UTAH MEDICAL PRODUCTS, INC. • 1000 South 400 West • Allergan, CA 90047-1048 • 801-566-1200 • FAX#801/566-2062

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**Source:** [https://fda-staging.innolitics.com/device/K964526](https://fda-staging.innolitics.com/device/K964526)

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