Cleared Traditional

K141812 - MYGAIT STIMULATION SYSTEM

K141812 is the FDA 510(k) clearance for MYGAIT STIMULATION SYSTEM by Otto Bock Healthcare Products GmbH. It is a Class 2 Neurology device (product code GZI) cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K141812 · Otto Bock Healthcare Products GmbH · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
269d
Days
Class 2
Risk

K141812 is an FDA 510(k) clearance for the MYGAIT STIMULATION SYSTEM. Classified as Stimulator, Neuromuscular, External Functional (product code GZI), Class II - Special Controls.

Submitted by Otto Bock Healthcare Products GmbH (Vienna, AT). The FDA issued a Cleared decision on April 2, 2015 after a review of 269 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5810 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Otto Bock Healthcare Products GmbH devices

Submission Details

510(k) Number K141812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2014
Decision Date April 02, 2015
Days to Decision 269 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 148d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZI Stimulator, Neuromuscular, External Functional
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5810
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 Neurology devices follow this clearance model.

Regulatory Peers - GZI Stimulator, Neuromuscular, External Functional

All 20
Devices cleared under the same product code (GZI) and FDA review panel - the closest regulatory comparables to K141812.
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FORTE ES
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SELECT NEUROMUSCULAR STIMULATORS
K903434 · Medtronic Vascular · Aug 1991