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)
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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.

View all Winner SG Pte, Ltd. devices

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
150d slower than avg
Panel avg: 115d · 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 105
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