Cleared Traditional

K162328 - Winner Transfer Wheelchair

K162328 is an FDA 510(k) clearance for Winner Transfer Wheelchair, manufactured by Winner SG Pte, Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K162328 · Winner SG Pte, Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
265d
Days
Class 1
Risk

K162328 is an FDA 510(k) clearance for the Winner Transfer Wheelchair. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Winner SG Pte, Ltd. (Singapore, SG). The FDA issued a Cleared decision on May 11, 2017 after a review of 265 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.

FDA 510(k) Submission Details - K162328

510(k) Number K162328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2016
Decision Date May 11, 2017
Days to Decision 265 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
149d slower than avg
Panel avg: 116d · This submission: 265d
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 424
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K162328.
Convaid Flyer FL12, FL13, FL14, FL15 and FL16
K171017 · Convaid Products, LLC · Oct 2017
Wheelchair
K163352 · Kunshan Hi-Fortune Health Products Co., Ltd. · Jul 2017
Stellar LEAP
K163432 · Pdg Product Design Group, Inc. · Jun 2017
Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair
K162621 · Invacare Corporation · Apr 2017
GEN_2 and GEN_3 Mechanical Wheelchairs
K170701 · Free Wheelchair Mission · Mar 2017
Kuschall Champion Manual Wheelchair
K162686 · Invacare Corporation · Dec 2016
K162328 · Winner Transfer Wheelchair
Download PDF FDA Summary Winner SG Pte, Ltd.