Cleared Traditional

K022602 - DRX3000

K022602 is an FDA 510(k) clearance for DRX3000, manufactured by Axiom Usa., Inc.. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K022602 · Axiom Usa., Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
170d
Days
Class 2
Risk

K022602 is an FDA 510(k) clearance for the DRX3000. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Axiom Usa., Inc. (Tampa, US). The FDA issued a Cleared decision on January 23, 2003 after a review of 170 days - an extended review 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: 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 Axiom Usa., Inc. devices

FDA 510(k) Submission Details - K022602

510(k) Number K022602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2002
Decision Date January 23, 2003
Days to Decision 170 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 115d · This submission: 170d
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 20
Devices cleared under the same product code (ITH) and FDA review panel - the closest regulatory comparables to K022602.
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