Cleared Traditional

K113065 - RL, UL, SL, EL, AND EPL VERTICAL PLATFORM LIFTS

K113065 is an FDA 510(k) clearance for RL, manufactured by Bella Elevator, LLC. The device is a Class 2 Physical Medicine device with product code ING cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K113065 · Bella Elevator, LLC · Physical Medicine device
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Feb 2012
Decision
131d
Days
Class 2
Risk

K113065 is an FDA 510(k) clearance for the RL, UL, SL, EL, AND EPL VERTICAL PLATFORM LIFTS. Classified as Elevator, Wheelchair, Portable (product code ING), Class II - Special Controls.

Submitted by Bella Elevator, LLC (Peoria, US). The FDA issued a Cleared decision on February 22, 2012 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3930 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Bella Elevator, LLC devices

FDA 510(k) Submission Details - K113065

510(k) Number K113065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2011
Decision Date February 22, 2012
Days to Decision 131 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 115d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ING Device Classification - Class 2, Special Controls

Product Code ING Elevator, Wheelchair, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3930
Definition A Motorized Lift Device That Is Not Permanently Mounted In One Location And That Is Intended For Medical Purposes To Provide A Means To Move A Person With Impaired Mobility, With Or Without A Wheelchair, From One Level To Another (e.g., Portable Platform Lifts, Attendant-operated Stair Climbing Devices For Wheelchairs).
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.