Cleared Traditional

K033827 - UB 140

K033827 is an FDA 510(k) clearance for UB 140, manufactured by Rivertrail Mobility. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K033827 · Rivertrail Mobility · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
8d
Days
Class 2
Risk

K033827 is an FDA 510(k) clearance for the UB 140. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Rivertrail Mobility (Clinton, US). The FDA issued a Cleared decision on December 18, 2003 after a review of 8 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 - K033827

510(k) Number K033827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2003
Decision Date December 18, 2003
Days to Decision 8 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
108d faster than avg
Panel avg: 116d · This submission: 8d
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.
N.E. 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 K033827.
STREET
K032765 · Permobil AB · Jan 2004
TANGO, MODELS, BP1
K031711 · American Bantex Corp. · Dec 2003
EPW FOLDABLE POWER WHEELCHAIR, EPW-03
K033206 · Emg Technology Co., Ltd. · Dec 2003
TAIWAN KING STRONG POWERED WHEELCHAIR, TP 01
K033100 · Taiwan King Strong Co., Ltd. · Dec 2003
POWERED WHEELCHAIR, MODEL FR168W
K033370 · Freerider Corp · Nov 2003
Y.E.S POWERED WHEELCHAIR. T180
K032512 · Yeou Eir Shuen Machinery Co., Ltd. · Nov 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.

K033827 · UB 140
Download PDF FDA Summary Rivertrail Mobility