Cleared Special

K100527 - HOVEROUND TEKNIQUE, MODEL HD-6

K100527 is an FDA 510(k) clearance for HOVEROUND TEKNIQUE, 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 30-day FDA review.

K100527 · Hoveround Corp. · Physical Medicine device
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Mar 2010
Decision
30d
Days
Class 2
Risk

K100527 is an FDA 510(k) clearance for the HOVEROUND TEKNIQUE, MODEL HD-6. 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 26, 2010 after a review of 30 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 - K100527

510(k) Number K100527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2010
Decision Date March 26, 2010
Days to Decision 30 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 116d · This submission: 30d
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 K100527.
ZIP'R MANTIS POWERED WHEELCHAIR
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K100327 · Heartway Medical Products Co., Ltd. · Mar 2010
HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT
K100350 · Hoveround Corp. · Mar 2010
AMIGO ESCORT 7.5, MODEL 760001 PHS
K092936 · Amigo Mobility Intl., Inc. · Dec 2009
K100527 · HOVEROUND TEKNIQUE, MODEL HD-6
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