Cleared Traditional

K061475 - ASTROTILT MANUAL WHEELCHAIR

K061475 is an FDA 510(k) clearance for ASTROTILT MANUAL WHEELCHAIR, manufactured by Pdg Product Design Group, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K061475 · Pdg Product Design Group, Inc. · Physical Medicine device
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Jun 2006
Decision
15d
Days
Class 1
Risk

K061475 is an FDA 510(k) clearance for the ASTROTILT MANUAL 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 June 14, 2006 after a review of 15 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

FDA 510(k) Submission Details - K061475

510(k) Number K061475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2006
Decision Date June 14, 2006
Days to Decision 15 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 115d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 126
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K061475.
BRAVORACER PEDIATRIC MANUAL WHEELCHAIR
K082314 · Otto Bock Healthcare LP · Oct 2008
START JUNIOR
K073512 · Otto Bock Healthcare LP · Jan 2008
QUICKIE QX MANUAL FOLDING WHEELCHAIR
K072153 · Sunrise Medical, Inc. · Sep 2007
INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR
K060582 · Invacare Corporation · Mar 2006
MEDLINE PEDIATRIC WHEELCHAIRS
K053574 · Medline Industries, Inc. · Jan 2006
START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI)
K052681 · Otto Bock Healthcare LP · Oct 2005