Cleared Traditional

K033263 - K-TECH 2 POWER TILT SEATING SYSTEM, MODEL K2PT

K033263 is an FDA 510(k) clearance for K-TECH 2 POWER TILT SEATING SYSTEM, manufactured by Track Corporation. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K033263 · Track Corporation · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
22d
Days
Class 2
Risk

K033263 is an FDA 510(k) clearance for the K-TECH 2 POWER TILT SEATING SYSTEM, MODEL K2PT. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Track Corporation (Spring Lake, US). The FDA issued a Cleared decision on October 31, 2003 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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 - K033263

510(k) Number K033263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2003
Decision Date October 31, 2003
Days to Decision 22 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
94d faster than avg
Panel avg: 116d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

ITI Device Classification - Class 2, Special Controls

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
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

Entela, Inc.
NED DEVINE

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 - ITI Wheelchair, Powered

All 589
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K033263.
POWERED WHEELCHAIR, MODEL FR168W
K033370 · Freerider Corp · Nov 2003
Y.E.S POWERED WHEELCHAIR. T180
K032512 · Yeou Eir Shuen Machinery Co., Ltd. · Nov 2003
TAIWAN KING STRONG POWERED WHEELCHAIR, TP 02
K033097 · Taiwan King Strong Co., Ltd. · Nov 2003
F-10 FOLDING POWER CHAIR
K032441 · Wheelchair & Scooter Express · Oct 2003
F-11 FOLDING POWER CHAIR
K032440 · Wheelchair & Scooter Express · Sep 2003
COACH 888W
K030760 · Wheelchair & Scooter Express · Jul 2003

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.

K033263 · K-TECH 2 POWER TILT SEATING SYSTEM, MODEL K2PT
Download PDF FDA Summary Track Corporation