Cleared Traditional

K910751 - FORTRESS 1600ACV REAR WHEEL DRIVE SCOOTER

K910751 is an FDA 510(k) clearance for FORTRESS 1600ACV REAR WHEEL DRIVE SCOOTER, manufactured by Fortress Litestyle. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K910751 · Fortress Litestyle · Physical Medicine device
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Apr 1991
Decision
60d
Days
Class 2
Risk

K910751 is an FDA 510(k) clearance for the FORTRESS 1600ACV REAR WHEEL DRIVE SCOOTER. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Fortress Litestyle (Washington, US). The FDA issued a Cleared decision on April 22, 1991 after a review of 60 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. 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.

View all Fortress Litestyle devices

FDA 510(k) Submission Details - K910751

510(k) Number K910751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1991
Decision Date April 22, 1991
Days to Decision 60 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 115d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 247
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K910751.
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K900600 · Invacare Corp. · Feb 1990