Cleared Traditional

K042482 - BASS ANTALGIC-TRAK

K042482 is an FDA 510(k) clearance for BASS ANTALGIC-TRAK, manufactured by Traction Masters, LLC. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K042482 · Traction Masters, LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
189d
Days
Class 2
Risk

K042482 is an FDA 510(k) clearance for the BASS ANTALGIC-TRAK. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Traction Masters, LLC (Parkland, US). The FDA issued a Cleared decision on March 21, 2005 after a review of 189 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.

FDA 510(k) Submission Details - K042482

510(k) Number K042482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2004
Decision Date March 21, 2005
Days to Decision 189 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
73d slower than avg
Panel avg: 116d · This submission: 189d
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 68
Devices cleared under the same product code (ITH) and FDA review panel - the closest regulatory comparables to K042482.
TRITON/TRU-TRAC/TX TRACTION DEVICES
K051938 · Chattanooga Group · Sep 2005
SPINA SYSTEM
K033231 · North American Medical Corp (Nam) · Sep 2005
SPINEMED S200B/S200C
K051013 · Cert Health Sciences, LLC · Apr 2005
HEALTHSTAR ELITE
K043239 · Hill Laboratories Co. · Dec 2004
EXTENTRAC ELITE
K031996 · Advanced Back Technologies · Jul 2004
SPINERX-LDM
K031862 · Spinerx Technology · Oct 2003
K042482 · BASS ANTALGIC-TRAK
Download PDF FDA Summary Traction Masters, LLC