Cleared Abbreviated

K031342 - JASON MARINE ALL TERRAIN ELECTRIC WHEELCHAIR, MODEL SEEKER II

K031342 is an FDA 510(k) clearance for JASON MARINE ALL TERRAIN ELECTRIC WHEEL..., manufactured by Jason Marine Enterprises, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Abbreviated 510(k) pathway after a 73-day FDA review.

K031342 · Jason Marine Enterprises, Inc. · Physical Medicine device
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Jul 2003
Decision
73d
Days
Class 2
Risk

K031342 is an FDA 510(k) clearance for the JASON MARINE ALL TERRAIN ELECTRIC WHEELCHAIR, MODEL SEEKER II. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Jason Marine Enterprises, Inc. (Coral Springs, US). The FDA issued a Cleared decision on July 10, 2003 after a review of 73 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K031342

510(k) Number K031342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2003
Decision Date July 10, 2003
Days to Decision 73 days
Submission Type Abbreviated
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
43d faster than avg
Panel avg: 116d · This submission: 73d
Pathway characteristics
Standards-based clearance path.

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 589
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K031342.
F-10 FOLDING POWER CHAIR
K032441 · Wheelchair & Scooter Express · Oct 2003
F-11 FOLDING POWER CHAIR
K032440 · Wheelchair & Scooter Express · Sep 2003
COACH 888W
K030760 · Wheelchair & Scooter Express · Jul 2003
COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB 202
K030355 · Comfort Orthopedic Co., Ltd. · May 2003
COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103
K030356 · Comfort Orthopedic Co., Ltd. · May 2003
QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424
K031289 · Sunrise Medical, Inc. · May 2003
K031342 · JASON MARINE ALL TERRAIN ELECTRIC WHEELCHAIR, MODEL SEEKER II
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