Cleared Traditional

K120032 - MECHANICAL WHEELCHAIR

K120032 is an FDA 510(k) clearance for MECHANICAL WHEELCHAIR, manufactured by Aikin Healthcare Co., Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K120032 · Aikin Healthcare Co., Ltd. · Physical Medicine device
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Apr 2012
Decision
100d
Days
Class 1
Risk

K120032 is an FDA 510(k) clearance for the MECHANICAL WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Aikin Healthcare Co., Ltd. (Greenwood Village, US). The FDA issued a Cleared decision on April 13, 2012 after a review of 100 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 Aikin Healthcare Co., Ltd. devices

FDA 510(k) Submission Details - K120032

510(k) Number K120032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2012
Decision Date April 13, 2012
Days to Decision 100 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 115d · This submission: 100d
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 93
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K120032.
Kuschall K-Series Attract Manual Wheelchair
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K162696 · Invacare Corporation · Dec 2016
MyOn HC Manual Wheelchair
K152536 · Invacare Corporation · Jan 2016
MEDLINE PEDIATRIC WHEELCHAIRS
K053574 · Medline Industries, Inc. · Jan 2006
EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR
K051302 · Medline Industries, Inc. · Aug 2005
MEDLINE EXCEL RECLINCER WHEELCHAIR
K013761 · Medline Industries, Inc. · Dec 2001