Cleared Special

K080219 - MODIFICATION TO:NESS L300

K080219 is an FDA 510(k) clearance for MODIFICATION TO:NESS L300, manufactured by Ness-Neuromuscular Electrical Stimulation Systems. 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.

K080219 · Ness-Neuromuscular Electrical Stimulation Systems · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
30d
Days
Class 2
Risk

K080219 is an FDA 510(k) clearance for the MODIFICATION TO:NESS L300. Classified as Stimulator, Neuromuscular, External Functional (product code GZI), Class II - Special Controls.

Submitted by Ness-Neuromuscular Electrical Stimulation Systems (Valencia, US). The FDA issued a Cleared decision on February 28, 2008 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.

FDA 510(k) Submission Details - K080219

510(k) Number K080219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2008
Decision Date February 28, 2008
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 56
Devices cleared under the same product code (GZI) and FDA review panel - the closest regulatory comparables to K080219.
RT600
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RT300-SL, MODEL FA100052
K090750 · Restorative Therapies, Inc. · Aug 2009
REHASTIM & REHAMOVE
K073237 · Hasomed GmbH · Dec 2007
RT300-S AND RT300-SP FES CYCLE ERGOMETER
K072398 · Restorative Therapies, Inc. · Nov 2007
RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053
K071486 · Restorative Therapies, Inc. · Sep 2007
K080219 · MODIFICATION TO:NESS L300
Download PDF FDA Summary Ness-Neuromuscular El…