Cleared Special

K011227 - REGAL MOTOTRIZED 3 WHEELED VEHICLE

K011227 is the FDA 510(k) clearance for REGAL MOTOTRIZED 3 WHEELED VEHICLE by Bruno Independent Living Aids, Inc.. It is a Class 2 Physical Medicine device (product code ITI) cleared through the Special 510(k) pathway after a 18-day FDA review.

K011227 · Bruno Independent Living Aids, Inc. · Physical Medicine device
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May 2001
Decision
18d
Days
Class 2
Risk

K011227 is an FDA 510(k) clearance for the REGAL MOTOTRIZED 3 WHEELED VEHICLE. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Bruno Independent Living Aids, Inc. (Oconomowoc, US). The FDA issued a Cleared decision on May 11, 2001 after a review of 18 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.

View all Bruno Independent Living Aids, Inc. devices

Submission Details

510(k) Number K011227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2001
Decision Date May 11, 2001
Days to Decision 18 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
97d faster than avg
Panel avg: 115d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 173
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