Cleared Traditional

K964526 - LIBERTY RECTAL PELVIC FLOOR EXERCISER

K964526 is an FDA 510(k) clearance for LIBERTY RECTAL PELVIC FLOOR EXERCISER, manufactured by Utah Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K964526 · Utah Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
90d
Days
Class 2
Risk

K964526 is an FDA 510(k) clearance for the LIBERTY RECTAL PELVIC FLOOR EXERCISER. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Utah Medical Products, Inc. (Midvale, US). The FDA issued a Cleared decision on February 10, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5320 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Utah Medical Products, Inc. devices

FDA 510(k) Submission Details - K964526

510(k) Number K964526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1996
Decision Date February 10, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPI Device Classification - Class 2, Special Controls

Product Code KPI Stimulator, Electrical, Non-implantable, For Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KPI Stimulator, Electrical, Non-implantable, For Incontinence

All 53
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K964526.
LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044)
K970077 · Utah Medical Products, Inc. · May 1997
MINNOVA PELVIC FLOOR STIMULATION SYSTEM
K970307 · Empi · Apr 1997
VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL
K970602 · Hollister, Inc. · Apr 1997
INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205)
K964577 · Empi · Jan 1997
MICROGYN PLUS STIMULATION DEVICE
K963222 · Hollister, Inc. · Oct 1996
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
K961872 · Hollister, Inc. · Aug 1996