Cleared Special

K111739 - KIDS ROCK 3 CHAIR

K111739 is an FDA 510(k) clearance for KIDS ROCK 3 CHAIR, manufactured by Pride Mobility Products Corp.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Special 510(k) pathway after a 52-day FDA review.

K111739 · Pride Mobility Products Corp. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
52d
Days
Class 1
Risk

K111739 is an FDA 510(k) clearance for the KIDS ROCK 3 CHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Pride Mobility Products Corp. (Exeter, US). The FDA issued a Cleared decision on August 12, 2011 after a review of 52 days - a notably fast clearance 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pride Mobility Products Corp. devices

FDA 510(k) Submission Details - K111739

510(k) Number K111739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2011
Decision Date August 12, 2011
Days to Decision 52 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
64d faster than avg
Panel avg: 116d · This submission: 52d
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 355
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K111739.
JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR
K112948 · Jiangsu Healthy Way Medical Equipment Co;Ltd · Mar 2012
JIANGSU HEALTHY WAY MECHANICL WHEELCHAIR
K112950 · Jiangsu Healthy Medical Equipment Co;Ltd · Mar 2012
YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR
K120526 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Mar 2012
CENTRO FAMILY OF MANUAL WHEELCHAIRS
K111045 · Otto Bock Healthcare LP · Jul 2011
INNOVA WHEELCHAIR
K110788 · Columbia Medical Manufacturing, LLC · May 2011
ICON ADULT MANUAL
K110985 · Icon Wheelchairs, Inc. · May 2011