Cleared Traditional

K032489 - WU'S 4-WHEELED NEO SCOOTER

K032489 is an FDA 510(k) clearance for WU'S 4-WHEELED NEO SCOOTER, manufactured by Wu'S Tech Co., Ltd.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K032489 · Wu'S Tech Co., Ltd. · Physical Medicine device
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Sep 2003
Decision
43d
Days
Class 2
Risk

K032489 is an FDA 510(k) clearance for the WU'S 4-WHEELED NEO SCOOTER, WT-M4JR. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Wu'S Tech Co., Ltd. (Hsin-Chu City, TW). The FDA issued a Cleared decision on September 24, 2003 after a review of 43 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 Wu'S Tech Co., Ltd. devices

FDA 510(k) Submission Details - K032489

510(k) Number K032489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2003
Decision Date September 24, 2003
Days to Decision 43 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
72d faster than avg
Panel avg: 115d · This submission: 43d
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 116
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K032489.
WU'S 3-WHEELED NEO SCOOTER, WT-T3D
K032488 · Wu'S Tech Co., Ltd. · Dec 2003
WU'S 4-WHEELED SCOOTER, WT-L4JR
K032617 · Wu'S Tech Co., Ltd. · Nov 2003
WU'S 3-WHEELED NEO SCOOTER, MODEL WT-M3JR
K033032 · Wu'S Tech Co., Ltd. · Nov 2003
INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3
K030814 · Invacare Corp. · Mar 2003
WU'S 3-WHEELED NEO SCOOTER, WT-L3
K023040 · Wu'S Tech Co., Ltd. · Jan 2003
WU'S 3-WHEELED NEO SCOOTER, WT-M4
K023166 · Wu'S Tech Co., Ltd. · Jan 2003