Cleared Traditional

K131529 - SHENGGUANG MANUAL WHEELCHAIR

K131529 is an FDA 510(k) clearance for SHENGGUANG MANUAL WHEELCHAIR, manufactured by Pingdingshan Shenxing Healthcare Technology Co., L. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K131529 · Pingdingshan Shenxing Healthcare Technology Co., L · Physical Medicine device
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Sep 2013
Decision
119d
Days
Class 1
Risk

K131529 is an FDA 510(k) clearance for the SHENGGUANG MANUAL WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Pingdingshan Shenxing Healthcare Technology Co., L (Pingdingshan City, Henan, CN). The FDA issued a Cleared decision on September 24, 2013 after a review of 119 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 Pingdingshan Shenxing Healthcare Technology Co., L devices

FDA 510(k) Submission Details - K131529

510(k) Number K131529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2013
Decision Date September 24, 2013
Days to Decision 119 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 116d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 324
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K131529.
CAPELLA
K130788 · Future Mobility Healthcare, Inc. · Dec 2013
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DISCOVERY TMAX MANUAL WHEELCHAIR
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