Cleared Traditional

K053468 - NESS L300

K053468 is an FDA 510(k) clearance for NESS L300, manufactured by Ness-Neuromuscular Electrical Stimulation Systems. The device is a Class 2 Neurology device with product code GZI cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K053468 · 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
Jul 2006
Decision
206d
Days
Class 2
Risk

K053468 is an FDA 510(k) clearance for the NESS L300. Classified as Stimulator, Neuromuscular, External Functional (product code GZI), Class II - Special Controls.

Submitted by Ness-Neuromuscular Electrical Stimulation Systems (Washington, US). The FDA issued a Cleared decision on July 7, 2006 after a review of 206 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.

FDA 510(k) Submission Details - K053468

510(k) Number K053468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2005
Decision Date July 07, 2006
Days to Decision 206 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
57d slower than avg
Panel avg: 149d · This submission: 206d
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 56
Devices cleared under the same product code (GZI) and FDA review panel - the closest regulatory comparables to K053468.
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K053468 · NESS L300
Download PDF FDA Summary Ness-Neuromuscular El…