Cleared Traditional

K152878 - SUNTEC Mechanical Wheelchair

K152878 is an FDA 510(k) clearance for SUNTEC Mechanical Wheelchair, manufactured by Danyang Suntec Auto Parts Co., Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K152878 · Danyang Suntec Auto Parts Co., Ltd. · Physical Medicine device
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Feb 2016
Decision
126d
Days
Class 1
Risk

K152878 is an FDA 510(k) clearance for the SUNTEC Mechanical Wheelchair, model ST-WL-1000. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Danyang Suntec Auto Parts Co., Ltd. (Zhenjiang, CN). The FDA issued a Cleared decision on February 3, 2016 after a review of 126 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.

View all Danyang Suntec Auto Parts Co., Ltd. devices

FDA 510(k) Submission Details - K152878

510(k) Number K152878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2015
Decision Date February 03, 2016
Days to Decision 126 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
11d slower than avg
Panel avg: 115d · This submission: 126d
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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