Cleared Traditional

K053503 - VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE)

K053503 is an FDA 510(k) clearance for VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE), manufactured by Vax-D Medical Technologies USA, L.C.. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K053503 · Vax-D Medical Technologies USA, L.C. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
12d
Days
Class 2
Risk

K053503 is an FDA 510(k) clearance for the VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE). Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Vax-D Medical Technologies USA, L.C. (Oldsmar, US). The FDA issued a Cleared decision on December 28, 2005 after a review of 12 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 - K053503

510(k) Number K053503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2005
Decision Date December 28, 2005
Days to Decision 12 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
104d faster than avg
Panel avg: 116d · This submission: 12d
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 64
Devices cleared under the same product code (ITH) and FDA review panel - the closest regulatory comparables to K053503.
DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM
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TRITON/TRU-TRAC/TX/TRITON DTS TRACTION
K053223 · Chattanooga Group · Feb 2006
TRACTION SYSTEM, DIGIT-TRAC 930
K052453 · Ever Prosperous Instrument, Inc. · Jan 2006
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

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.

K053503 · VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE)
Download PDF FDA Summary Vax-D Medical Technol…