Cleared Traditional

K093946 - HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2

K093946 is an FDA 510(k) clearance for HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2, manufactured by Hoveround Corp.. The device is a Class 2 Physical Medicine device with product code ILK cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K093946 · Hoveround Corp. · Physical Medicine device
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Mar 2010
Decision
89d
Days
Class 2
Risk

K093946 is an FDA 510(k) clearance for the HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2. Classified as Transport, Patient, Powered (product code ILK), Class II - Special Controls.

Submitted by Hoveround Corp. (Sarasota, US). The FDA issued a Cleared decision on March 22, 2010 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5150 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K093946

510(k) Number K093946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2009
Decision Date March 22, 2010
Days to Decision 89 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 116d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILK Device Classification - Class 2, Special Controls

Product Code ILK Transport, Patient, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5150
Definition A Powered Patient Transport Is A Motorized Device Intended For Use In Mitigating Mobility Impairment Caused By Injury Or Other Disease By Moving A Person From One Location Or Level To Another, Such As Up And Down Flights Of Stairs (e.g., Attendant-operated Portable Stair-climbing Chairs). This Generic Type Of Device Does Not Include Motorized Three-wheeled Vehicles Or 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.

Regulatory Peers - ILK Transport, Patient, Powered

All 23
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K033829 · Bruno Independent Living Aids, Inc. · Dec 2003
K093946 · HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2
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