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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
60d slower than avg
Panel avg: 116d · 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 466
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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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
K141691 · GEN_3
Download PDF FDA Summary Free Wheelchair Missi…