Cleared Traditional

K944574 - LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI)

K944574 is an FDA 510(k) clearance for LUMEX WHEELCHAIRS (SER. 1000, manufactured by Lumex, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K944574 · Lumex, Inc. · Physical Medicine device
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Oct 1994
Decision
28d
Days
Class 1
Risk

K944574 is an FDA 510(k) clearance for the LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI). Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Lumex, Inc. (Bay Shore, US). The FDA issued a Cleared decision on October 17, 1994 after a review of 28 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.

View all Lumex, Inc. devices

FDA 510(k) Submission Details - K944574

510(k) Number K944574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1994
Decision Date October 17, 1994
Days to Decision 28 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
87d faster than avg
Panel avg: 115d · This submission: 28d
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 188
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K944574.
BUDDY WHEELCHAIR
K960402 · Metro-Care · Feb 1996
QUICKIE TSR
K952641 · Sunrise Medical, Inc. · Jul 1995
MODELS PHOENIX AND CONCEPT 45 MANUAL MECHANICAL WHEELCHAIRS
K951138 · Invacare Corp. · Mar 1995
SCC22/ SCC26 SHOWER COMMODE CHAIR
K943293 · O'Tec Corp. · Aug 1994
STRYKER BACK-SAVER STRETCHER CHAIR MODEL 6320
K941088 · Stryker Corp. · Apr 1994
ACTION PATRIOT MANUAL WHEELCHAIR
K930803 · Invacare Corp. · Mar 1994