Cleared Traditional

K972487 - EMG RETRAINER

K972487 is an FDA 510(k) clearance for EMG RETRAINER, manufactured by Chattanooga Group, Inc.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K972487 · Chattanooga Group, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
86d
Days
Class 2
Risk

K972487 is an FDA 510(k) clearance for the EMG RETRAINER. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Chattanooga Group, Inc. (Hixson, US). The FDA issued a Cleared decision on September 26, 1997 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - 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 Chattanooga Group, Inc. devices

FDA 510(k) Submission Details - K972487

510(k) Number K972487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 148d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 - HCC Device, Biofeedback

All 7
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K972487.
POLYGRAM NET BIOFEEDBACK APPLICATION
K041244 · Medtronic Vascular · Aug 2004
SONDREX P.A.L. SYSTEM
K010388 · Ohmeda Medical · Dec 2001
EAR MUFFINS
K012384 · Bio-Logic Systems Corp. · Oct 2001
J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS
K945826 · Medical Device Inspection Co., Inc. · Aug 1995