Cleared Special

K101277 - ORION II (HEAVY DUTY 350 LBS AND 500 LBS) (FDA 510(k) Clearance)

Class I Physical Medicine device.

K101277 · Future Mobility Healthcare, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
29d
Days
Class 1
Risk

K101277 is an FDA 510(k) clearance for the ORION II (HEAVY DUTY 350 LBS AND 500 LBS). Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Future Mobility Healthcare, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on June 4, 2010 after a review of 29 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 Future Mobility Healthcare, Inc. devices

Submission Details

510(k) Number K101277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2010
Decision Date June 04, 2010
Days to Decision 29 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 455
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K101277.
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