Cleared Traditional

K063736 - FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50

K063736 is an FDA 510(k) clearance for FUZE MECHANICAL 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 30-day FDA review.

K063736 · Pdg Product Design Group, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
30d
Days
Class 1
Risk

K063736 is an FDA 510(k) clearance for the FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Pdg Product Design Group, Inc. (Cleveland, US). The FDA issued a Cleared decision on January 17, 2007 after a review of 30 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 - K063736

510(k) Number K063736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2006
Decision Date January 17, 2007
Days to Decision 30 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 116d · This submission: 30d
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 423
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K063736.
QUICKIE QX MANUAL FOLDING WHEELCHAIR
K072153 · Sunrise Medical, Inc. · Sep 2007
MECHANICAL WHEELCHAIR - L-FRAME SERIES
K071444 · Colours 'N Motion · Jul 2007
MAXHEALTH MECHANICAL WHEELCHAIR, K1
K070176 · Maxhealth Corp. · Mar 2007
CATALYSY
K062660 · Ki Mobility, LLC · Oct 2006
KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105
K062309 · Karma Medical Products Co., Ltd. · Oct 2006
KARMA MANUAL WHEELCHAIR, MODEL BUDGET 800
K062311 · Karma Medical Products Co., Ltd. · Oct 2006
K063736 · FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50
Download PDF FDA Summary Pdg Product Design Gr…