Cleared Traditional

K030250 - IGLIDE MANUAL ASSIST WHEELCHAIR

K030250 is an FDA 510(k) clearance for IGLIDE MANUAL ASSIST WHEELCHAIR, manufactured by Independence Technology, LLC. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K030250 · Independence Technology, LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
39d
Days
Class 2
Risk

K030250 is an FDA 510(k) clearance for the IGLIDE MANUAL ASSIST WHEELCHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Independence Technology, LLC (Warren, US). The FDA issued a Cleared decision on March 4, 2003 after a review of 39 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 - K030250

510(k) Number K030250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2003
Decision Date March 04, 2003
Days to Decision 39 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
77d faster than avg
Panel avg: 116d · This submission: 39d
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 585
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K030250.
WU'S POWERED WHEELCHAIR, MAMBO 3
K030707 · Wu'S Tech Co., Ltd. · Apr 2003
WU'S POWERED WHEELCHAIR, MAMBO 5
K030709 · Wu'S Tech Co., Ltd. · Apr 2003
FRONTIER MODEL X5
K030783 · Vestil Manufacturing Corp. · Apr 2003
TEH LIN POWERED WHEELCHAIR, MODEL MDG-201
K022696 · Teh Lin Prosthetic & Orthopaedic, Inc. · Feb 2003
TEH LIN JUPITER POWER CHAIR, MODEL TL-320
K022697 · Teh Lin Prosthetic & Orthopaedic, Inc. · Jan 2003
EPW POWERED WHEELCHAIR, GP-201
K023148 · Emg Technology Co., Ltd. · Jan 2003
K030250 · IGLIDE MANUAL ASSIST WHEELCHAIR
Download PDF FDA Summary Independence Technolo…