Cleared Traditional

K103212 - ROUGHRIDER

K103212 is an FDA 510(k) clearance for ROUGHRIDER, manufactured by Whirlwind Wheelchair International. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K103212 · Whirlwind Wheelchair International · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
63d
Days
Class 1
Risk

K103212 is an FDA 510(k) clearance for the ROUGHRIDER. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Whirlwind Wheelchair International (San Francisco, US). The FDA issued a Cleared decision on January 3, 2011 after a review of 63 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. 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.

FDA 510(k) Submission Details - K103212

510(k) Number K103212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2010
Decision Date January 03, 2011
Days to Decision 63 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
53d faster than avg
Panel avg: 116d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

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 424
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K103212.
INNOVA WHEELCHAIR
K110788 · Columbia Medical Manufacturing, LLC · May 2011
ICON ADULT MANUAL
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K103073 · Future Mobility Healthcare, Inc. · Jan 2011
MODEL LUNA MANUAL WHEELCHAIR
K102910 · P.D.G., Inc. · Dec 2010
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K102061 · Patmont Motor Werks, Inc. · Dec 2010
24 WIDEN WHEELCHAIR (JY/CT-H28), 18 RECLINING WHEELCHAIR (JY-260), 18 LIGHT WEIGHT WHEELCHAIR (JY/CT-H06), 18 ALUMIN
K102110 · Foshan Shunde Jaeyong Hardware Co., Ltd. · Oct 2010
K103212 · ROUGHRIDER
Download PDF FDA Summary Whirlwind Wheelchair …