Cleared Traditional

K160139 - Luggie Chair

K160139 is an FDA 510(k) clearance for Luggie Chair, manufactured by Freerider Corporation. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 424-day FDA review.

K160139 · Freerider Corporation · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
424d
Days
Class 2
Risk

K160139 is an FDA 510(k) clearance for the Luggie Chair. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Freerider Corporation (Kang-Shan Dist, TW). The FDA issued a Cleared decision on March 20, 2017 after a review of 424 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Freerider Corporation devices

FDA 510(k) Submission Details - K160139

510(k) Number K160139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2016
Decision Date March 20, 2017
Days to Decision 424 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
309d slower than avg
Panel avg: 115d · This submission: 424d
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 241
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K160139.
SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP
K173313 · Eurogreen International, Inc. · Feb 2018
SupaChair Powered Wheelchair
K173315 · Eurogreen International, Inc. · Feb 2018
Invacare® TDX® SP2 Power Wheelchair
K170507 · Invacare Corporation · Jul 2017
HEARTWAY Electrically Powered Wheelchair P27
K142783 · Heartway Medical Products Co., Ltd. · Jun 2015
HEARTWAY Electrically Powered Wheelchairs
K142731 · Heartway Medical Products Co., Ltd. · Feb 2015
TDX SP2 POWER WHEECHAIR
K141783 · Invacare Corporation · Jan 2015