Cleared Traditional

K033370 - POWERED WHEELCHAIR, MODEL FR168W

K033370 is an FDA 510(k) clearance for POWERED WHEELCHAIR, manufactured by Freerider Corp. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K033370 · Freerider Corp · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
38d
Days
Class 2
Risk

K033370 is an FDA 510(k) clearance for the POWERED WHEELCHAIR, MODEL FR168W. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Freerider Corp (Phoenix, US). The FDA issued a Cleared decision on November 28, 2003 after a review of 38 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 - K033370

510(k) Number K033370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2003
Decision Date November 28, 2003
Days to Decision 38 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
78d faster than avg
Panel avg: 116d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - ITI Wheelchair, Powered

All 504
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K033370.
EPW FOLDABLE POWER WHEELCHAIR, EPW-03
K033206 · Emg Technology Co., Ltd. · Dec 2003
UB 140
K033827 · Rivertrail Mobility · Dec 2003
TAIWAN KING STRONG POWERED WHEELCHAIR, TP 01
K033100 · Taiwan King Strong Co., Ltd. · Dec 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
K-TECH 2 POWER TILT SEATING SYSTEM, MODEL K2PT
K033263 · Track Corporation · Oct 2003