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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 149d · 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 56
Devices cleared under the same product code (GZI) and FDA review panel - the closest regulatory comparables to K031900.
WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000
K052329 · Innovative Neurotronics, Inc. · Sep 2005
THE ODFS DROPPED FOOT STIMULATOR
K050991 · Department of Medical Physics and Biomedical Eng. · Jul 2005
FES CYCLE ERGOMETER, MODEL RT300-S
K050036 · Restorative Therapies, Inc. · Jun 2005
MODIFICATION TO HANDMASTER
K012823 · Ness-Neuromuscular Electrical Stimulation Systems · Nov 2001
HANDMASTER
K010837 · Neuromusclar Electrical Stimulation Systems, Ltd. · Jun 2001
EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR
K974514 · Neuromotion, Inc. · Feb 1998
K031900 · HANDMASTER
Download PDF FDA Summary Ness-Neuromuscular El…