Cleared Traditional

K031116 - VECTRA (INTELECT) EPR ULTRASOUND

K031116 is an FDA 510(k) clearance for VECTRA (INTELECT) EPR ULTRASOUND, manufactured by Chattanooga Group. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K031116 · Chattanooga Group · Physical Medicine device
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Dec 2003
Decision
239d
Days
Class 2
Risk

K031116 is an FDA 510(k) clearance for the VECTRA (INTELECT) EPR ULTRASOUND. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Chattanooga Group (Hixson, US). The FDA issued a Cleared decision on December 3, 2003 after a review of 239 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5300 - 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 - K031116

510(k) Number K031116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2003
Decision Date December 03, 2003
Days to Decision 239 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
124d slower than avg
Panel avg: 115d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMI Device Classification - Class 2, Special Controls

Product Code IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5300
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 - IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

All 51
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K031116.
ACCUSONIC ADVANTAGE
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K031329 · Dynatronics Corp. · Oct 2003
ACCOUSONIC, MODEL AS-270
K030878 · Metron Medical Australia, Pty, Ltd. · Mar 2003
ACCOUSONIC PLUS, MODEL AP-170
K030410 · Metron Medical Australia, Pty, Ltd. · Feb 2003