Cleared Traditional

K073132 - MODEL D DISC FORCE

K073132 is an FDA 510(k) clearance for MODEL D DISC FORCE, manufactured by North American Medical Corp (Nam). The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K073132 · North American Medical Corp (Nam) · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
148d
Days
Class 2
Risk

K073132 is an FDA 510(k) clearance for the MODEL D DISC FORCE. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by North American Medical Corp (Nam) (Marietta, US). The FDA issued a Cleared decision on April 3, 2008 after a review of 148 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 - K073132

510(k) Number K073132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2007
Decision Date April 03, 2008
Days to Decision 148 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 116d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K073132.
MTD 4000
K091540 · Mettler Electronics Corp. · Oct 2009
TM-400
K081247 · Ito Co., Ltd. · Aug 2008
GRAVILAX TRACTION SYSTEM
K072064 · Therapeutic Clinical Technologies, Inc. · Apr 2008
CYCLETRAC CT-5000
K073542 · Pt Products, LLC · Feb 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

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K073132 · MODEL D DISC FORCE
Download PDF FDA Summary North American Medica…