Cleared Traditional

K896025 - THE SHUTTLE (TM) THREE WHEEL SCOOTER

K896025 is the FDA 510(k) clearance for THE SHUTTLE (TM) THREE WHEEL SCOOTER by Pride Health Care, Inc.. It is a Class 2 Physical Medicine device (product code INI) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K896025 · Pride Health Care, Inc. · Physical Medicine device
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Nov 1989
Decision
36d
Days
Class 2
Risk

K896025 is an FDA 510(k) clearance for the THE SHUTTLE (TM) THREE WHEEL SCOOTER. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Pride Health Care, Inc. (Pittston, US). The FDA issued a Cleared decision on November 22, 1989 after a review of 36 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 Pride Health Care, Inc. devices

Submission Details

510(k) Number K896025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1989
Decision Date November 22, 1989
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.