Cleared Special

K112815 - QUANTUM BARIATRIC 451

K112815 is an FDA 510(k) clearance for QUANTUM BARIATRIC 451, manufactured by Pride Mobility Product Corporration. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Special 510(k) pathway after a 155-day FDA review.

K112815 · Pride Mobility Product Corporration · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
155d
Days
Class 2
Risk

K112815 is an FDA 510(k) clearance for the QUANTUM BARIATRIC 451. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Pride Mobility Product Corporration (Exeter, US). The FDA issued a Cleared decision on February 29, 2012 after a review of 155 days - an extended review 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. Standard predicate reliance. 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 Product Corporration devices

FDA 510(k) Submission Details - K112815

510(k) Number K112815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2011
Decision Date February 29, 2012
Days to Decision 155 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
40d slower than avg
Panel avg: 115d · This submission: 155d
Pathway characteristics
Modification to existing cleared device.

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 265
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