Cleared Abbreviated

K031996 - EXTENTRAC ELITE

K031996 is an FDA 510(k) clearance for EXTENTRAC ELITE, manufactured by Advanced Back Technologies. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Abbreviated 510(k) pathway after a 392-day FDA review.

K031996 · Advanced Back Technologies · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
392d
Days
Class 2
Risk

K031996 is an FDA 510(k) clearance for the EXTENTRAC ELITE. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Advanced Back Technologies (Syosset, US). The FDA issued a Cleared decision on July 23, 2004 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5900 - the FDA physical medicine device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Advanced Back Technologies devices

FDA 510(k) Submission Details - K031996

510(k) Number K031996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2003
Decision Date July 23, 2004
Days to Decision 392 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
277d slower than avg
Panel avg: 115d · This submission: 392d
Pathway characteristics
Standards-based clearance path.

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 12
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