Cleared Special

K141691 - GEN_3

K141691 is an FDA 510(k) clearance for GEN_3, manufactured by Free Wheelchair Mission. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Special 510(k) pathway after a 176-day FDA review.

K141691 · Free Wheelchair Mission · Physical Medicine device
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Dec 2014
Decision
176d
Days
Class 1
Risk

K141691 is an FDA 510(k) clearance for the GEN_3. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Free Wheelchair Mission (Yorba Linda, US). The FDA issued a Cleared decision on December 17, 2014 after a review of 176 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Free Wheelchair Mission devices

FDA 510(k) Submission Details - K141691

510(k) Number K141691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2014
Decision Date December 17, 2014
Days to Decision 176 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 115d · This submission: 176d
Pathway characteristics
Modification to existing cleared device.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
Definition A Mechanical Wheelchair Is A Manually 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/or Require An Assistive Device For Mobility.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IOR Wheelchair, Mechanical

All 220
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K141691.
P.R.O. CG Manual Wheelchair
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Helio A7 Manual Wheelchair, Move Manual Wheelchair
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ELEVATION
K140023 · Pdg Product Design Group, Inc. · Oct 2014
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K140416 · Convaid Products, Inc. · Sep 2014
VALENTINE STEEL WHEELCHAIR
K130017 · Valentine Intl. , Ltd. · May 2014