Cleared Special

K133826 - INTONEMV (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K133826 · Incontrol Medical, LLC · Gastroenterology & Urology device
Jan 2014
Decision
20d
Days
Class 2
Risk

K133826 is an FDA 510(k) clearance for the INTONEMV. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Incontrol Medical, LLC (Brookfield, US). The FDA issued a Cleared decision on January 6, 2014 after a review of 20 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K133826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2013
Decision Date January 06, 2014
Days to Decision 20 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
136d faster than avg
Panel avg: 156d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 7
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K133826.
Well-Life Incontinence Stimulation System (WL-2405i(P))
K251760 · Well-Life Healthcare , Ltd. · Feb 2026
Regenesis EMS Chair
K251026 · Trinity Medical Solutions · Aug 2025
NeuroTrac® MyoPlus Pro (MYO120U)
K243079 · Verity Medical , Ltd. · Jun 2025
BTL-398
K241516 · BTL Industries, Inc. · Feb 2025
Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode
K222528 · Well-Life Healthcare Limited · Dec 2022
Everyway Incontinence Stimulation System
K213116 · Everyway Medical Instruments Co.,Ltd · Dec 2021