Cleared Traditional

K112816 - ZHENJIANG ASURE MECHANICAL WHEELCHAIR

K112816 is an FDA 510(k) clearance for ZHENJIANG ASURE MECHANICAL WHEELCHAIR, manufactured by Zhenjiang Assure Medical Equipment Co., Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K112816 · Zhenjiang Assure Medical Equipment Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
203d
Days
Class 1
Risk

K112816 is an FDA 510(k) clearance for the ZHENJIANG ASURE MECHANICAL WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Zhenjiang Assure Medical Equipment Co., Ltd. (Hsin Chu City, TW). The FDA issued a Cleared decision on April 18, 2012 after a review of 203 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 Zhenjiang Assure Medical Equipment Co., Ltd. devices

FDA 510(k) Submission Details - K112816

510(k) Number K112816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2011
Decision Date April 18, 2012
Days to Decision 203 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 116d · This submission: 203d
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 313
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