Cleared Traditional

K854497 - VOYAGEUR, BUTTERFLY ONE, CADET LAURENTIAN, HORIZON

K854497 is an FDA 510(k) clearance for VOYAGEUR, manufactured by Canadian Wheelchair. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K854497 · Canadian Wheelchair · Physical Medicine device
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Dec 1985
Decision
20d
Days
Class 1
Risk

K854497 is an FDA 510(k) clearance for the VOYAGEUR, BUTTERFLY ONE, CADET LAURENTIAN, HORIZON. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Canadian Wheelchair (Mississauga,Ontario, CA). The FDA issued a Cleared decision on December 2, 1985 after a review of 20 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 Canadian Wheelchair devices

FDA 510(k) Submission Details - K854497

510(k) Number K854497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1985
Decision Date December 02, 1985
Days to Decision 20 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 115d · This submission: 20d
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 254
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K854497.
POIRIER KID-ROLLER MANUAL WHEELCHAIR
K874317 · Roseburg SA · Nov 1987
2000LT WHEELCHAIR
K864901 · Invacare Corp. · Dec 1986
POIRIER MANUAL WHEELCHAIR
K864790 · Roseburg SA · Dec 1986
THE MOVER
K853424 · Invacare Corp. · Nov 1985
CRS ULTRALITE PREMIER
K851257 · Everest & Jennings, Inc. · Jun 1985
PLAIN JANE SERIES WHEELCHAIR
K842232 · Invacare Corp. · Jun 1984