Cleared Traditional

K033142 - POWERED WHEELCHAIR

K033142 is an FDA 510(k) clearance for POWERED WHEELCHAIR, manufactured by Nats Corp.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K033142 · Nats Corp. · Physical Medicine device
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May 2004
Decision
232d
Days
Class 2
Risk

K033142 is an FDA 510(k) clearance for the POWERED WHEELCHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Nats Corp. (Sound Beach, US). The FDA issued a Cleared decision on May 19, 2004 after a review of 232 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K033142

510(k) Number K033142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2003
Decision Date May 19, 2004
Days to Decision 232 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 115d · This submission: 232d
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 379
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K033142.
INVACARE 3G TARSYS
K033819 · Invacare Corp. · Jun 2004
GOLDEN SPYDER, MODEL GS-300
K041341 · Golden Technologies, Inc. · Jun 2004
A&I POWER WHEELCHAIR, PC-401
K041190 · Well Success Biotech, Inc. · May 2004
QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424
K031289 · Sunrise Medical, Inc. · May 2003
WU'S POWERED WHEELCHAIR, MAMBO 3
K030707 · Wu'S Tech Co., Ltd. · Apr 2003
WU'S POWERED WHEELCHAIR, MAMBO 5
K030709 · Wu'S Tech Co., Ltd. · Apr 2003