Cleared Traditional

K090108 - HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR

K090108 is an FDA 510(k) clearance for HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR, manufactured by Hoveround Corp.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K090108 · Hoveround Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
63d
Days
Class 2
Risk

K090108 is an FDA 510(k) clearance for the HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Hoveround Corp. (Sarasota, US). The FDA issued a Cleared decision on March 19, 2009 after a review of 63 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 - K090108

510(k) Number K090108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2009
Decision Date March 19, 2009
Days to Decision 63 days
Submission Type Traditional
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
53d faster than avg
Panel avg: 116d · This submission: 63d
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 530
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K090108.
RASCAL WE GO 250 POWERED WHEELCHAIR
K092130 · Electric Mobility Corp. · Sep 2009
FREEDOM SCIENCES MOTION CONTROL MODULE VERSION 1.5
K091723 · Freedom Sciences, LLC · Jul 2009
EXTREME 4X4-X8 POWER WHEELCHAIR
K090350 · Vestil Manufacturing Corp. · Apr 2009
QUICKIE RHYTHM
K083249 · Sunrise Medical Hhg, Inc. · Dec 2008
P & F POWER WHEELCHAIR, MODEL HC-500SB
K082722 · P & F Brother Ind., Corp. · Oct 2008
HAIDA HD21
K082288 · Jiangyin East China Medical Technology Co., Ltd. · Aug 2008
K090108 · HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR
Download PDF Hoveround Corp.