Cleared Traditional

K062483 - MINI POWER CHAIR, MODEL MN 5000

K062483 is an FDA 510(k) clearance for MINI POWER CHAIR, manufactured by Line Ind.(Shanghai) Co., Ltd.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K062483 · Line Ind.(Shanghai) Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
14d
Days
Class 2
Risk

K062483 is an FDA 510(k) clearance for the MINI POWER CHAIR, MODEL MN 5000. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Line Ind.(Shanghai) Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on September 8, 2006 after a review of 14 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 Line Ind.(Shanghai) Co., Ltd. devices

FDA 510(k) Submission Details - K062483

510(k) Number K062483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2006
Decision Date September 08, 2006
Days to Decision 14 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 332
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K062483.
WU'S POWERED WHEELCHAIR, MAMBO 36
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K052706 · Otto Bock Healthcare LP · Dec 2005
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K052559 · Wu'S Tech Co., Ltd. · Sep 2005
Z-CHAIR
K052353 · Pride Mobility Products Corp. · Sep 2005