Cleared Traditional

EMG RETRAINER

K972487 · Chattanooga Group, Inc. · Neurology
Sep 1997
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K972487 is an FDA 510(k) clearance for the EMG RETRAINER, a Device, Biofeedback (Class II — Special Controls, product code HCC), submitted by Chattanooga Group, Inc. (Hixson, US). The FDA issued a Cleared decision on September 26, 1997, 86 days after receiving the submission on July 2, 1997. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number K972487 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 1997
Decision Date September 26, 1997
Days to Decision 86 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HCC — Device, Biofeedback
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5050