Cleared Traditional

K092225 - AMYPOWER ALL TRACK SERIES POWER WHEELCHAIR

K092225 is an FDA 510(k) clearance for AMYPOWER ALL TRACK SERIES POWER WHEELCHAIR, manufactured by Amylior, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K092225 · Amylior, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
78d
Days
Class 2
Risk

K092225 is an FDA 510(k) clearance for the AMYPOWER ALL TRACK SERIES POWER WHEELCHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Amylior, Inc. (Quebec, CA). The FDA issued a Cleared decision on October 9, 2009 after a review of 78 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.

View all Amylior, Inc. devices

FDA 510(k) Submission Details - K092225

510(k) Number K092225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2009
Decision Date October 09, 2009
Days to Decision 78 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
37d faster than avg
Panel avg: 115d · This submission: 78d
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 295
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K092225.
HEARTWAY POWER CHAIR, P23
K100327 · Heartway Medical Products Co., Ltd. · Mar 2010
HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT
K100350 · Hoveround Corp. · Mar 2010
JAZZY FRONTIE
K092961 · Pride Mobility Products Corp. · Oct 2009
HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR
K090108 · Hoveround Corp. · Mar 2009
A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I
K073134 · Invacare Corporation · Nov 2007
HEARTWAY LIGHTWEIGHT POWER CHAIR, P15
K071005 · Heartway Medical Products Co., Ltd. · May 2007