Cleared Traditional

K943936 - XLT, REA COMFORT, SPIREA, ZOOM

K943936 is an FDA 510(k) clearance for XLT, manufactured by Electric Mobility Corp.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K943936 · Electric Mobility Corp. · Physical Medicine device
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Sep 1994
Decision
40d
Days
Class 1
Risk

K943936 is an FDA 510(k) clearance for the XLT, REA COMFORT, SPIREA, ZOOM. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Electric Mobility Corp. (Sewell, US). The FDA issued a Cleared decision on September 21, 1994 after a review of 40 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 - K943936

510(k) Number K943936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1994
Decision Date September 21, 1994
Days to Decision 40 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 116d · This submission: 40d
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 466
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K943936.
MECHANICAL WHEELCHAIR - BOING
K945534 · Colours 'N Motion · Jan 1995
SOLUTION
K944970 · Freedom Designs, Inc. · Dec 1994
LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI)
K944574 · Lumex, Inc. · Oct 1994
DAB WELDLESS WHEELCHAIR
K944122 · Da Intl. , Ltd. · Sep 1994
SCC22/ SCC26 SHOWER COMMODE CHAIR
K943293 · O'Tec Corp. · Aug 1994
WHEELCHAIR,MECHANICAL
K941976 · Tone World International · Jun 1994
K943936 · XLT, REA COMFORT, SPIREA, ZOOM
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