Cleared Traditional

K023993 - GALAXY SERIES WHEELCHAIR

K023993 is an FDA 510(k) clearance for GALAXY SERIES WHEELCHAIR, manufactured by Evermed Corp.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K023993 · Evermed Corp. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
24d
Days
Class 1
Risk

K023993 is an FDA 510(k) clearance for the GALAXY SERIES WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Evermed Corp. (Anaheim, US). The FDA issued a Cleared decision on December 27, 2002 after a review of 24 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 - K023993

510(k) Number K023993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2002
Decision Date December 27, 2002
Days to Decision 24 days
Submission Type Traditional
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
92d faster than avg
Panel avg: 116d · This submission: 24d
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 465
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K023993.
STAINLESS STEEL AQUATIC WHEELCHAIR
K031910 · Db Perks & Associates , Ltd. · Jul 2003
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CHUMP
K030017 · Colours 'N Motion · May 2003
TILITE EVO
K024055 · Tisport, LLC · Dec 2002
MILLENNIUM SERIES MANUAL WHEELCHAIRS
K024030 · Evermed Corp. · Dec 2002
GIZMO
K023574 · Freedom Designs, Inc. · Dec 2002
K023993 · GALAXY SERIES WHEELCHAIR
Download PDF FDA Summary Evermed Corp.