Cleared Traditional

K051369 - SYRYKER SORANO WHEELCHAIR

K051369 is an FDA 510(k) clearance for SYRYKER SORANO WHEELCHAIR, manufactured by Stryker Canada. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K051369 · Stryker Canada · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
123d
Days
Class 1
Risk

K051369 is an FDA 510(k) clearance for the SYRYKER SORANO WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Stryker Canada (Hamilton Ontario, CA). The FDA issued a Cleared decision on September 26, 2005 after a review of 123 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K051369

510(k) Number K051369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2005
Decision Date September 26, 2005
Days to Decision 123 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
7d slower than avg
Panel avg: 116d · This submission: 123d
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 452
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K051369.
A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P
K052586 · Taiwan an I Co., Ltd. · Dec 2005
START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI)
K052681 · Otto Bock Healthcare LP · Oct 2005
YK9000 SERIES MANUAL WHEELCHAIR
K052468 · Intco Metal Products (Zhenjiang) Co., Ltd. · Oct 2005
NISSIN SERIES MECHANICAL WHEELCHAIR
K052521 · Nissin Medical Industries Co., Ltd. · Sep 2005
EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR
K051302 · Medline Industries, Inc. · Aug 2005
JAN MAO WHEELCHAIR, MODEL JMC611-F18EPP
K051481 · Jan Mao Industries Co., Ltd. · Jun 2005
K051369 · SYRYKER SORANO WHEELCHAIR
Download PDF FDA Summary Stryker Canada