Cleared Traditional

K001712 - 3D ACTIVETRAC

K001712 is an FDA 510(k) clearance for 3D ACTIVETRAC, manufactured by The Saunders Group. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K001712 · The Saunders Group · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
87d
Days
Class 2
Risk

K001712 is an FDA 510(k) clearance for the 3D ACTIVETRAC. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by The Saunders Group (Chaska, US). The FDA issued a Cleared decision on August 31, 2000 after a review of 87 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 - K001712

510(k) Number K001712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2000
Decision Date August 31, 2000
Days to Decision 87 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
29d faster than avg
Panel avg: 116d · This submission: 87d
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 70
Devices cleared under the same product code (ITH) and FDA review panel - the closest regulatory comparables to K001712.
DRX3000
K022602 · Axiom Usa., Inc. · Jan 2003
DRX5000
K023160 · Axiom Usa., Inc. · Dec 2002
DRX 2000
K010292 · Axiom Worldwide, Inc. · May 2001
SPINA SYSTEM
K002260 · North American Medical Corporation (Nam) · Aug 2000
JILCO TRACTION-FLEXION CHAIR
K001361 · Jilco Enterprises · Jul 2000
SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM
K001296 · Cavendish Scott, Inc. · Jul 2000
K001712 · 3D ACTIVETRAC
Download PDF FDA Summary The Saunders Group