Cleared Traditional

K010292 - DRX 2000

K010292 is an FDA 510(k) clearance for DRX 2000, 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 90-day FDA review.

K010292 · 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 2001
Decision
90d
Days
Class 2
Risk

K010292 is an FDA 510(k) clearance for the DRX 2000. 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 1, 2001 after a review of 90 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 - K010292

510(k) Number K010292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2001
Decision Date May 01, 2001
Days to Decision 90 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
26d faster than avg
Panel avg: 116d · This submission: 90d
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 64
Devices cleared under the same product code (ITH) and FDA review panel - the closest regulatory comparables to K010292.
SPINEMED
K030060 · Cert Health Sciences, LLC · Feb 2003
DRX3000
K022602 · Axiom Usa., Inc. · Jan 2003
DRX5000
K023160 · Axiom Usa., Inc. · Dec 2002
3D ACTIVETRAC
K001712 · The Saunders Group · Aug 2000
SPINA SYSTEM
K002260 · North American Medical Corporation (Nam) · Aug 2000
JILCO TRACTION-FLEXION CHAIR
K001361 · Jilco Enterprises · Jul 2000
K010292 · DRX 2000
Download PDF FDA Summary Axiom Worldwide, Inc.