Cleared Special

K021136 - TEKNIQUE-HOVEROUND POWER WHEEL CHAIR

K021136 is an FDA 510(k) clearance for TEKNIQUE-HOVEROUND POWER WHEEL CHAIR, manufactured by Hoveround Corp.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Special 510(k) pathway after a 10-day FDA review.

K021136 · Hoveround Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
10d
Days
Class 2
Risk

K021136 is an FDA 510(k) clearance for the TEKNIQUE-HOVEROUND POWER WHEEL CHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Hoveround Corp. (Sarasota, US). The FDA issued a Cleared decision on April 19, 2002 after a review of 10 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K021136

510(k) Number K021136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2002
Decision Date April 19, 2002
Days to Decision 10 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 116d · This submission: 10d
Pathway characteristics
Modification to existing cleared device.

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 530
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K021136.
TIPOWER TR RIMPOWER AND TIPOWER TRA RIMPOWER
K020639 · Tisport · Jun 2002
INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91
K021680 · Invacare Corp. · Jun 2002
Y.E.S 10 WHEELCHAIR
K021255 · Movingpeople.Net · May 2002
KARMA DISCOVERY, MODEL KP40
K014127 · Vestil Manufacturing Corp. · Mar 2002
WIN-2 TANGO ELITE NP
K013361 · Durable Medical Equipment, Inc. · Feb 2002
OMEGATRAC, MODEL Z105
K013307 · Teftec Corp. · Feb 2002
K021136 · TEKNIQUE-HOVEROUND POWER WHEEL CHAIR
Download PDF Hoveround Corp.