Cleared Special

K120853 - NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,

K120853 is an FDA 510(k) clearance for NESS L300 SYSTEM KIT, manufactured by Bioness, Inc.. The device is a Class 2 Neurology device with product code GZI cleared through the Special 510(k) pathway after a 30-day FDA review.

K120853 · Bioness, Inc. · Neurology device
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Apr 2012
Decision
30d
Days
Class 2
Risk

K120853 is an FDA 510(k) clearance for the NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYST.... Classified as Stimulator, Neuromuscular, External Functional (product code GZI), Class II - Special Controls.

Submitted by Bioness, Inc. (Valencia, US). The FDA issued a Cleared decision on April 20, 2012 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5810 - the FDA neurology 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.

View all Bioness, Inc. devices

FDA 510(k) Submission Details - K120853

510(k) Number K120853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2012
Decision Date April 20, 2012
Days to Decision 30 days
Submission Type Special
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
119d faster than avg
Panel avg: 149d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 55
Devices cleared under the same product code (GZI) and FDA review panel - the closest regulatory comparables to K120853.
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