Cleared Traditional

K031077 - VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM

K031077 is an FDA 510(k) clearance for VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM, manufactured by Chattanooga Group. The device is a Class 2 Physical Medicine device with product code IMG cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K031077 · Chattanooga Group · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
251d
Days
Class 2
Risk

K031077 is an FDA 510(k) clearance for the VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM. Classified as Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (product code IMG), Class II - Special Controls.

Submitted by Chattanooga Group (Hixson, US). The FDA issued a Cleared decision on December 11, 2003 after a review of 251 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5860 - the FDA physical medicine 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Chattanooga Group devices

FDA 510(k) Submission Details - K031077

510(k) Number K031077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2003
Decision Date December 11, 2003
Days to Decision 251 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 115d · This submission: 251d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMG Device Classification - Class 2, Special Controls

Product Code IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5860
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

All 39
Devices cleared under the same product code (IMG) and FDA review panel - the closest regulatory comparables to K031077.
SONICATOR PLUS 920
K111482 · Mettler Electronics Corp. · Aug 2011
CT2011 SONICSTIMU PAIN RELIEF DEVICE
K092627 · Shenzhen Dongdixin Technology Co., Ltd. · Jan 2010
SONICATOR PLUS 940, MODEL ME940
K071137 · Mettler Electronics Corp. · Aug 2007
VECTORSONIC, MODEL VU-270
K030880 · Metron Medical Australia, Pty, Ltd. · Apr 2003
RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI
K023050 · Reliant Technologies, Inc. · Feb 2003
VECTORSONIC, MODEL VU-200
K020119 · Metron Medical Australia, Pty, Ltd. · Jul 2002