Cleared Traditional

K153328 - SUNCO Mechanical Wheelchair

K153328 is an FDA 510(k) clearance for SUNCO Mechanical Wheelchair, manufactured by Danyang Sunco Machinery Co., Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K153328 · Danyang Sunco Machinery Co., Ltd. · Physical Medicine device
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Jul 2016
Decision
244d
Days
Class 1
Risk

K153328 is an FDA 510(k) clearance for the SUNCO Mechanical Wheelchair, model SKW-9003. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Danyang Sunco Machinery Co., Ltd. (Danyang City, CN). The FDA issued a Cleared decision on July 20, 2016 after a review of 244 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 Danyang Sunco Machinery Co., Ltd. devices

FDA 510(k) Submission Details - K153328

510(k) Number K153328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2015
Decision Date July 20, 2016
Days to Decision 244 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
129d slower than avg
Panel avg: 115d · This submission: 244d
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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