Cleared Traditional

K110985 - ICON ADULT MANUAL

K110985 is an FDA 510(k) clearance for ICON ADULT MANUAL, manufactured by Icon Wheelchairs, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K110985 · Icon Wheelchairs, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
25d
Days
Class 1
Risk

K110985 is an FDA 510(k) clearance for the ICON ADULT MANUAL. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Icon Wheelchairs, Inc. (Northampton, US). The FDA issued a Cleared decision on May 3, 2011 after a review of 25 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 - K110985

510(k) Number K110985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2011
Decision Date May 03, 2011
Days to Decision 25 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 116d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IOR Wheelchair, Mechanical

All 424
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K110985.
KIDS ROCK 3 CHAIR
K111739 · Pride Mobility Products Corp. · Aug 2011
CENTRO FAMILY OF MANUAL WHEELCHAIRS
K111045 · Otto Bock Healthcare LP · Jul 2011
INNOVA WHEELCHAIR
K110788 · Columbia Medical Manufacturing, LLC · May 2011
SUPER CHAIR FOR KIDS BY ORION
K103073 · Future Mobility Healthcare, Inc. · Jan 2011
ROUGHRIDER
K103212 · Whirlwind Wheelchair International · Jan 2011
MODEL LUNA MANUAL WHEELCHAIR
K102910 · P.D.G., Inc. · Dec 2010

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K110985 · ICON ADULT MANUAL
Download PDF FDA Summary Icon Wheelchairs, Inc.