Cleared Traditional

K141812 - MYGAIT STIMULATION SYSTEM

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

K141812 · Otto Bock Healthcare Products GmbH · Neurology device
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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

FDA 510(k) Submission Details - K141812

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
Combination Product No
PCCP Authorized No
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.

GZI Device Classification - Class 2, Special Controls

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 42
Devices cleared under the same product code (GZI) and FDA review panel - the closest regulatory comparables to K141812.
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K132416 · Hasomed GmbH · May 2014