Cleared Traditional

K974514 - EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR

K974514 is an FDA 510(k) clearance for EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMU..., manufactured by Neuromotion, Inc.. The device is a Class 2 Neurology device with product code GZI cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K974514 · Neuromotion, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
67d
Days
Class 2
Risk

K974514 is an FDA 510(k) clearance for the EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR. Classified as Stimulator, Neuromuscular, External Functional (product code GZI), Class II - Special Controls.

Submitted by Neuromotion, Inc. (Edmonton, Alberta, CA). The FDA issued a Cleared decision on February 6, 1998 after a review of 67 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Neuromotion, Inc. devices

FDA 510(k) Submission Details - K974514

510(k) Number K974514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1997
Decision Date February 06, 1998
Days to Decision 67 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
81d faster than avg
Panel avg: 148d · This submission: 67d
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 28
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