Cleared Traditional

K100668 - NEMA-ST, MODEL V1.0.2

K100668 is an FDA 510(k) clearance for NEMA-ST, manufactured by Nervomatrix, Ltd.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K100668 · Nervomatrix, Ltd. · Neurology device
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Optimized for regulatory review, auditing and printing
Dec 2010
Decision
274d
Days
Class 2
Risk

K100668 is an FDA 510(k) clearance for the NEMA-ST, MODEL V1.0.2. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Nervomatrix, Ltd. (Haifa, IL). The FDA issued a Cleared decision on December 8, 2010 after a review of 274 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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.

View all Nervomatrix, Ltd. devices

FDA 510(k) Submission Details - K100668

510(k) Number K100668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2010
Decision Date December 08, 2010
Days to Decision 274 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 148d · This submission: 274d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 178
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