Cleared Traditional

K020539 - TIPOWER POWERDRIVE AND RIMPOWER X & SX

K020539 is an FDA 510(k) clearance for TIPOWER POWERDRIVE AND RIMPOWER X & SX, manufactured by Tisport. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K020539 · Tisport · Physical Medicine device
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Jun 2002
Decision
121d
Days
Class 2
Risk

K020539 is an FDA 510(k) clearance for the TIPOWER POWERDRIVE AND RIMPOWER X & SX. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Tisport (Kennewick, US). The FDA issued a Cleared decision on June 20, 2002 after a review of 121 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Tisport devices

FDA 510(k) Submission Details - K020539

510(k) Number K020539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2002
Decision Date June 20, 2002
Days to Decision 121 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 115d · This submission: 121d
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 325
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K020539.
WU'S POWERED WHEELCHAIR, MAMBO 5
K030709 · Wu'S Tech Co., Ltd. · Apr 2003
HOVEROUND REHAB SEATING SYSTEM FOR POWER WHEELCHAIRS
K022993 · Hoveround Corp. · Dec 2002
STORM TDX POWER WHEELCHAIR
K023589 · Invacare Corp. · Nov 2002
INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91
K021680 · Invacare Corp. · Jun 2002
TEKNIQUE-HOVEROUND POWER WHEEL CHAIR
K021136 · Hoveround Corp. · Apr 2002
INVACARE ELEVATING SEAT OPTION ESS6
K013516 · Invacare Corp. · Dec 2001