Cleared Traditional

K990557 - THE STELLAR TILT

K990557 is the FDA 510(k) clearance for THE STELLAR TILT by Pdg Product Design Group, Inc.. It is a Class 1 Physical Medicine device (product code IOR) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K990557 · Pdg Product Design Group, Inc. · Physical Medicine device
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Mar 1999
Decision
28d
Days
Class 1
Risk

K990557 is an FDA 510(k) clearance for the THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Pdg Product Design Group, Inc. (Vancouver, Bc, CA). The FDA issued a Cleared decision on March 22, 1999 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 Pdg Product Design Group, Inc. devices

Submission Details

510(k) Number K990557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1999
Decision Date March 22, 1999
Days to Decision 28 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
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.

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 77
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K990557.
MODEL 9000 BARIATRIC WHEELCHAIR
K002317 · Invacare Corp. · Aug 2000
MODEL 9000 PEDIATRIC WHEELCHAIR
K002170 · Invacare Corp. · Aug 2000
ACTION AF-1 WHEELCHAIR
K000174 · Invacare Corp. · Feb 2000
MODEL TOP END TERMINATOR SS MANUAL WHEELCHAIR
K990157 · Invacare Corp. · Feb 1999
MODEL ACTION AT II MANUAL WHEELCHAIR
K984447 · Invacare Corp. · Jan 1999
KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS
K982336 · Invacare Corp. · Aug 1998