Cleared Abbreviated

K061116 - MOBILLIFE - MODEL (MOBIL RAIZER 22) - POWER WHEELCHAIR

K061116 is an FDA 510(k) clearance for MOBILLIFE - MODEL (MOBIL RAIZER 22) - P..., manufactured by Mobilife, LLC. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Abbreviated 510(k) pathway after a 73-day FDA review.

K061116 · Mobilife, LLC · Physical Medicine device
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Jul 2006
Decision
73d
Days
Class 2
Risk

K061116 is an FDA 510(k) clearance for the MOBILLIFE - MODEL (MOBIL RAIZER 22) - POWER WHEELCHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Mobilife, LLC (Delafield, US). The FDA issued a Cleared decision on July 3, 2006 after a review of 73 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K061116

510(k) Number K061116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2006
Decision Date July 03, 2006
Days to Decision 73 days
Submission Type Abbreviated
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
43d faster than avg
Panel avg: 116d · This submission: 73d
Pathway characteristics
Standards-based clearance path.

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 585
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K061116.
QUICKIE RHAPSODY, MWD SERIES II POWER WHEELCHAIR
K062701 · Sunrise Medical, Inc. · Sep 2006
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K062483 · Line Ind.(Shanghai) Co., Ltd. · Sep 2006
FORYOU POWERED WHEELCHAIR, MODEL FC-100
K061693 · Foryou Technology Co., Ltd. · Jul 2006
QUICKIE RHYTHM & GROOVE SERIES POWER WHEELCHAIRS W/QUICKIE DELPHI CONTROLS
K060531 · Sunrise Medical · Mar 2006
TACAHE
K052534 · Dalton Medical Corp. · Jan 2006
A-200 POWERED WHEELCHAIR
K052706 · Otto Bock Healthcare LP · Dec 2005
K061116 · MOBILLIFE - MODEL (MOBIL RAIZER 22) - POWER WHEELCHAIR
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