Cleared Special

K080288 - TRAVEL PAL FOUR WHEEL SCOOTER, MODEL MM114

K080288 is an FDA 510(k) clearance for TRAVEL PAL FOUR WHEEL SCOOTER, manufactured by Mega Motion, Inc.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Special 510(k) pathway after a 11-day FDA review.

K080288 · Mega Motion, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
11d
Days
Class 2
Risk

K080288 is an FDA 510(k) clearance for the TRAVEL PAL FOUR WHEEL SCOOTER, MODEL MM114. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Mega Motion, Inc. (Old Forge, US). The FDA issued a Cleared decision on February 15, 2008 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3800 - 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 Mega Motion, Inc. devices

FDA 510(k) Submission Details - K080288

510(k) Number K080288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2008
Decision Date February 15, 2008
Days to Decision 11 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 115d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

INI Device Classification - Class 2, Special Controls

Product Code INI Vehicle, Motorized 3-wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3800
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 - INI Vehicle, Motorized 3-wheeled

All 174
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