Cleared Traditional

K053223 - TRITON/TRU-TRAC/TX/TRITON DTS TRACTION

K053223 is an FDA 510(k) clearance for TRITON/TRU-TRAC/TX/TRITON DTS TRACTION, manufactured by Chattanooga Group. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K053223 · Chattanooga Group · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
99d
Days
Class 2
Risk

K053223 is an FDA 510(k) clearance for the TRITON/TRU-TRAC/TX/TRITON DTS TRACTION. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Chattanooga Group (Hixson, US). The FDA issued a Cleared decision on February 24, 2006 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5900 - 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.

FDA 510(k) Submission Details - K053223

510(k) Number K053223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2005
Decision Date February 24, 2006
Days to Decision 99 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 116d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITH Device Classification - Class 2, Special Controls

Product Code ITH Equipment, Traction, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5900
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 - ITH Equipment, Traction, Powered

All 61
Devices cleared under the same product code (ITH) and FDA review panel - the closest regulatory comparables to K053223.
VAX-D GENESIS G2 SYSTEM
K071347 · Vax-D Medical Technologies, LLC · Oct 2007
CTBOX CERVICAL/LUMBAR TRACTION
K063353 · Circular Traction Supply, Inc. · Mar 2007
DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM
K060735 · Axiom Worldwide, Inc. · May 2006
TRACTION SYSTEM, DIGIT-TRAC 930
K052453 · Ever Prosperous Instrument, Inc. · Jan 2006
VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE)
K053503 · Vax-D Medical Technologies USA, L.C. · Dec 2005
TRITON/TRU-TRAC/TX TRACTION DEVICES
K051938 · Chattanooga Group · Sep 2005
K053223 · TRITON/TRU-TRAC/TX/TRITON DTS TRACTION
Download PDF FDA Summary Chattanooga Group