Cleared Traditional

K102031 - GALAXY LITE (FDA 510(k) Clearance)

Class I Physical Medicine device.

K102031 · Future Mobility Healthcare, Inc. · Physical Medicine device
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Oct 2010
Decision
93d
Days
Class 1
Risk

K102031 is an FDA 510(k) clearance for the GALAXY LITE. 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 October 20, 2010 after a review of 93 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Future Mobility Healthcare, Inc. devices

Submission Details

510(k) Number K102031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2010
Decision Date October 20, 2010
Days to Decision 93 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
22d faster than avg
Panel avg: 115d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

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 K102031.
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