Cleared Traditional

K915659 - THREE WHEEL SCOOTER

K915659 is an FDA 510(k) clearance for THREE WHEEL SCOOTER, manufactured by Pride Health Care, Inc.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K915659 · Pride Health Care, Inc. · Physical Medicine device
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Jan 1992
Decision
34d
Days
Class 2
Risk

K915659 is an FDA 510(k) clearance for the 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 January 21, 1992 after a review of 34 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.

FDA 510(k) Submission Details - K915659

510(k) Number K915659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1991
Decision Date January 21, 1992
Days to Decision 34 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
82d faster than avg
Panel avg: 116d · This submission: 34d
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 354
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K915659.
FORTRESS 1800FS REAR WHEEL DRIVE SCOOTER
K921069 · Fortress Scientific , Ltd. · Apr 1992
DRAKE & DRAKE/200 DL
K921467 · Am Scooters · Apr 1992
SHOPRIDER - TE889
K920654 · Pride Health Care, Inc. · Mar 1992
510 DL POWERED WHEELCHAIRS
K913989 · Am Scooters · Oct 1991
FORTRESS 1600ACV REAR WHEEL DRIVE SCOOTER
K910751 · Fortress Litestyle · Apr 1991
TRAVELER, MOTORIZED THREE-WHEELED VEHICLE
K910265 · Pillar Technology, Inc. · Feb 1991
K915659 · THREE WHEEL SCOOTER
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