Cleared Traditional

K163432 - Stellar LEAP

K163432 is an FDA 510(k) clearance for Stellar LEAP, 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 202-day FDA review.

K163432 · Pdg Product Design Group, Inc. · Physical Medicine device
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Jun 2017
Decision
202d
Days
Class 1
Risk

K163432 is an FDA 510(k) clearance for the Stellar LEAP. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Pdg Product Design Group, Inc. (Vancouver, CA). The FDA issued a Cleared decision on June 27, 2017 after a review of 202 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Pdg Product Design Group, Inc. devices

FDA 510(k) Submission Details - K163432

510(k) Number K163432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2016
Decision Date June 27, 2017
Days to Decision 202 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 slower than avg
Panel avg: 115d · This submission: 202d
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 126
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K163432.
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