Cleared Traditional

K053434 - MYOTRAC INFINITI ELECTRICAL STIMULATOR

K053434 is an FDA 510(k) clearance for MYOTRAC INFINITI ELECTRICAL STIMULATOR, manufactured by Thought Technology , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K053434 · Thought Technology , Ltd. · Gastroenterology & Urology device
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Mar 2006
Decision
96d
Days
Class 2
Risk

K053434 is an FDA 510(k) clearance for the MYOTRAC INFINITI ELECTRICAL STIMULATOR. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Thought Technology , Ltd. (Montreal, Quebec, CA). The FDA issued a Cleared decision on March 15, 2006 after a review of 96 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 Thought Technology , Ltd. devices

FDA 510(k) Submission Details - K053434

510(k) Number K053434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2005
Decision Date March 15, 2006
Days to Decision 96 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 131d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

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ROBERT MOSENKIS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 79
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K053434.
INCONTROL
K110179 · Incontrol Medical, LLC · Feb 2012
TENSCARE ITOUCH SURE MODEL ITS
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UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES
K070331 · Laborie Medical Technologies · May 2007
SKYLARK URO PROBE
K053007 · Skylark Device & Systems Co., Ltd. · Dec 2005
EVADRI BLADDER CONTROL SYSTEMS
K050483 · Hollister, Inc. · Apr 2005
MICROGYN PLUS STIMULATION DEVICE
K013141 · Hollister, Inc. · Dec 2001

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.