Cleared Special

K090805 - V10

K090805 is an FDA 510(k) clearance for V10, manufactured by Pride Mobility Products Corp.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Special 510(k) pathway after a 9-day FDA review.

K090805 · Pride Mobility Products Corp. · Physical Medicine device
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Apr 2009
Decision
9d
Days
Class 2
Risk

K090805 is an FDA 510(k) clearance for the V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610.... Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Pride Mobility Products Corp. (Exeter, US). The FDA issued a Cleared decision on April 3, 2009 after a review of 9 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 Pride Mobility Products Corp. devices

FDA 510(k) Submission Details - K090805

510(k) Number K090805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2009
Decision Date April 03, 2009
Days to Decision 9 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 115d · This submission: 9d
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 128
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K090805.
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