Cleared Traditional

WHEEL-O-VATOR (K934553) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K934553 · The National Wheel-O-Vator Co., Inc. · Physical Medicine device
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Feb 1994
Decision
149d
Days
Class 2
Risk

K934553 is an FDA 510(k) clearance for the WHEEL-O-VATOR. Classified as Elevator, Wheelchair, Portable (product code ING), Class II - Special Controls.

Submitted by The National Wheel-O-Vator Co., Inc. (Roanoke, US). The FDA issued a Cleared decision on February 17, 1994 after a review of 149 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 The National Wheel-O-Vator Co., Inc. devices

Submission Details

510(k) Number K934553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1993
Decision Date February 17, 1994
Days to Decision 149 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 115d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.