Cleared Traditional

K964577 - INNOVA COMFORTPULSE VAGINAL ELECTRODE (...

K964577 is the FDA 510(k) clearance for INNOVA COMFORTPULSE VAGINAL ELECTRODE (... by Empi. It is a Class 2 Gastroenterology & Urology device (product code KPI) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K964577 · Empi · Gastroenterology & Urology device
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Jan 1997
Decision
71d
Days
Class 2
Risk

K964577 is an FDA 510(k) clearance for the INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGI.... Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Empi (St. Paul, US). The FDA issued a Cleared decision on January 24, 1997 after a review of 71 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Empi devices

Submission Details

510(k) Number K964577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1996
Decision Date January 24, 1997
Days to Decision 71 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
59d faster than avg
Panel avg: 130d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 47
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K964577.
VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON
K971541 · Hollister, Inc. · Jun 1997
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K970307 · Empi · Apr 1997
VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL
K970602 · Hollister, Inc. · Apr 1997
MICROGYN PLUS STIMULATION DEVICE
K963222 · Hollister, Inc. · Oct 1996
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
K961872 · Hollister, Inc. · Aug 1996
INNOVA RECTAL STIMULATON ELECTRODE
K954272 · Empi · Apr 1996