Cleared Traditional

K060735 - DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM

K060735 is an FDA 510(k) clearance for DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM, manufactured by Axiom Worldwide, Inc.. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K060735 · Axiom Worldwide, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
67d
Days
Class 2
Risk

K060735 is an FDA 510(k) clearance for the DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Axiom Worldwide, Inc. (Tampa, US). The FDA issued a Cleared decision on May 26, 2006 after a review of 67 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K060735

510(k) Number K060735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2006
Decision Date May 26, 2006
Days to Decision 67 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 116d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv Rheinland of North America, Inc.
TAMAS BORSAI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ITH Equipment, Traction, Powered

All 64
Devices cleared under the same product code (ITH) and FDA review panel - the closest regulatory comparables to K060735.
CYCLETRAC CT-5000
K073542 · Pt Products, LLC · Feb 2008
VAX-D GENESIS G2 SYSTEM
K071347 · Vax-D Medical Technologies, LLC · Oct 2007
CTBOX CERVICAL/LUMBAR TRACTION
K063353 · Circular Traction Supply, Inc. · Mar 2007
TRITON/TRU-TRAC/TX/TRITON DTS TRACTION
K053223 · Chattanooga Group · Feb 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

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K060735 · DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM
Download PDF FDA Summary Axiom Worldwide, Inc.