Cleared Traditional

FORTE ES

K940759 · Chattanooga Group, Inc. · Neurology
Mar 1995
Decision
391d
Days
Class 2
Risk

About This 510(k) Submission

K940759 is an FDA 510(k) clearance for the FORTE ES, a Stimulator, Neuromuscular, External Functional (Class II — Special Controls, product code GZI), submitted by Chattanooga Group, Inc. (Hixson, US). The FDA issued a Cleared decision on March 16, 1995, 391 days after receiving the submission on February 18, 1994. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5810.

Submission Details

510(k) Number K940759 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code GZI — Stimulator, Neuromuscular, External Functional
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5810