Cleared Traditional

K940759 - FORTE ES

K940759 is an FDA 510(k) clearance for FORTE ES, manufactured by Chattanooga Group, Inc.. The device is a Class 2 Neurology device with product code GZI cleared through the Traditional 510(k) pathway after a 391-day FDA review.

K940759 · Chattanooga Group, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
391d
Days
Class 2
Risk

K940759 is an FDA 510(k) clearance for the FORTE ES. Classified as Stimulator, Neuromuscular, External Functional (product code GZI), Class II - Special Controls.

Submitted by Chattanooga Group, Inc. (Hixson, US). The FDA issued a Cleared decision on March 16, 1995 after a review of 391 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Chattanooga Group, Inc. devices

FDA 510(k) Submission Details - K940759

510(k) Number K940759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1994
Decision Date March 16, 1995
Days to Decision 391 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
243d slower than avg
Panel avg: 148d · This submission: 391d
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 19
Devices cleared under the same product code (GZI) and FDA review panel - the closest regulatory comparables to K940759.
L300 Go System
K190285 · Bioness, Inc. · Mar 2019
L300 Go System
K173682 · Bioness, Inc. · Mar 2018
ODFS Pace XL
K171396 · Odstock Medical, Ltd. · Jan 2018
ROCHE COBAS ARGOS 5 DIFF
K912615 · Roche Diagnostic Systems, Inc. · Sep 1991
SELECT NEUROMUSCULAR STIMULATORS
K903434 · Medtronic Vascular · Aug 1991
FES ORTHOSIS MODEL NO. 2000
K800380 · Empi · Mar 1980