Cleared Traditional

K073542 - CYCLETRAC CT-5000

K073542 is an FDA 510(k) clearance for CYCLETRAC CT-5000, manufactured by Pt Products, LLC. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K073542 · Pt Products, LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
59d
Days
Class 2
Risk

K073542 is an FDA 510(k) clearance for the CYCLETRAC CT-5000. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Pt Products, LLC (Farmington Hills, US). The FDA issued a Cleared decision on February 14, 2008 after a review of 59 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 - K073542

510(k) Number K073542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2007
Decision Date February 14, 2008
Days to Decision 59 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
57d faster than avg
Panel avg: 116d · This submission: 59d
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 K073542.
TM-400
K081247 · Ito Co., Ltd. · Aug 2008
GRAVILAX TRACTION SYSTEM
K072064 · Therapeutic Clinical Technologies, Inc. · Apr 2008
MODEL D DISC FORCE
K073132 · North American Medical Corp (Nam) · Apr 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
DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM
K060735 · Axiom Worldwide, Inc. · May 2006
K073542 · CYCLETRAC CT-5000
Download PDF FDA Summary Pt Products, LLC