Cleared Traditional

K030759 - LITTLE COACH

K030759 is an FDA 510(k) clearance for LITTLE COACH, manufactured by Wheelchair & Scooter Express. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K030759 · Wheelchair & Scooter Express · Physical Medicine device
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May 2003
Decision
51d
Days
Class 2
Risk

K030759 is an FDA 510(k) clearance for the LITTLE COACH. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Wheelchair & Scooter Express (Houston, US). The FDA issued a Cleared decision on May 1, 2003 after a review of 51 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 - K030759

510(k) Number K030759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2003
Decision Date May 01, 2003
Days to Decision 51 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
65d faster than avg
Panel avg: 116d · This submission: 51d
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 353
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K030759.
COACH 888
K030758 · Wheelchair & Scooter Express · Jul 2003
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JI-EE ELECTRIC SCOOTER, ESTHETE ES 1
K024325 · Ji-Ee Industry Co., Ltd. · Apr 2003
JI-EE ELECTRIC SCOOTER, ELEGANCE ES 3
K024329 · Ji-Ee Industry Co., Ltd. · Mar 2003
INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3
K030814 · Invacare Corp. · Mar 2003
K030759 · LITTLE COACH
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