Cleared Traditional

K030709 - WU'S POWERED WHEELCHAIR

K030709 is an FDA 510(k) clearance for WU'S POWERED WHEELCHAIR, manufactured by Wu'S Tech Co., Ltd.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K030709 · Wu'S Tech Co., Ltd. · Physical Medicine device
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Apr 2003
Decision
29d
Days
Class 2
Risk

K030709 is an FDA 510(k) clearance for the WU'S POWERED WHEELCHAIR, MAMBO 5. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Wu'S Tech Co., Ltd. (Hsin-Chu City, TW). The FDA issued a Cleared decision on April 4, 2003 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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 - K030709

510(k) Number K030709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2003
Decision Date April 04, 2003
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITI Device Classification - Class 2, Special Controls

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
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 - ITI Wheelchair, Powered

All 220
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K030709.
WU'S POWERED WHEELCHAIR, MAMBO F 120
K050011 · Wu'S Tech Co., Ltd. · Feb 2005
INVACARE 3G TARSYS
K033819 · Invacare Corp. · Jun 2004
WU'S POWERED WHEELCHAIR, MAMBO 3
K030707 · Wu'S Tech Co., Ltd. · Apr 2003
STORM TDX POWER WHEELCHAIR
K023589 · Invacare Corp. · Nov 2002
INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91
K021680 · Invacare Corp. · Jun 2002
INVACARE ELEVATING SEAT OPTION ESS6
K013516 · Invacare Corp. · Dec 2001