Cleared Special

K031900 - HANDMASTER

K031900 is an FDA 510(k) clearance for HANDMASTER, 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 50-day FDA review.

K031900 · Ness-Neuromuscular Electrical Stimulation Systems · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
50d
Days
Class 2
Risk

K031900 is an FDA 510(k) clearance for the HANDMASTER. 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 August 8, 2003 after a review of 50 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 Ness-Neuromuscular Electrical Stimulation Systems devices

FDA 510(k) Submission Details - K031900

510(k) Number K031900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2003
Decision Date August 08, 2003
Days to Decision 50 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 148d · This submission: 50d
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 20
Devices cleared under the same product code (GZI) and FDA review panel - the closest regulatory comparables to K031900.
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