Cleared Traditional

K082963 - WU'S 4-WHEELED NEO SCOOTER, WT-M3A

K082963 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 52-day FDA review.

K082963 · Wu'S Tech Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
52d
Days
Class 2
Risk

K082963 is an FDA 510(k) clearance for the WU'S 4-WHEELED NEO SCOOTER, WT-M3A. 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 November 24, 2008 after a review of 52 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 - K082963

510(k) Number K082963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2008
Decision Date November 24, 2008
Days to Decision 52 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 116d · This submission: 52d
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 K082963.
V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS, V10, FOUR WHEEL SCOOTER, MODEL SC710
K090805 · Pride Mobility Products Corp. · Apr 2009
GO GO ELITE TRAVELER V THREE WHEEL SCOOTER, MODEL SC40EV
K090524 · Pride Mobility Products Corp. · Mar 2009
LANDLEX, MODEL: 402X
K083303 · Besteam Technology, Inc. · Jan 2009
KYMCO FORU, MODEL EQ10
K082900 · Kwang Yang Motor Co., Ltd. · Oct 2008
KYMCO FORU, MODEL EQ20
K082901 · Kwang Yang Motor Co., Ltd. · Oct 2008
KYMCO FORU, MODEL EQ35
K081980 · Besteam Technology, Inc. · Aug 2008
K082963 · WU'S 4-WHEELED NEO SCOOTER, WT-M3A
Download PDF FDA Summary Wu'S Tech Co., Ltd.