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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 116d · 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 327
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K120032.
COMED K-SERIES MANUAL WHEELCHAIR
K120077 · Danyang Comed Healthcare Co., Ltd. · May 2012
GEN_2 MECHANICAL WHEELCHAIR
K113713 · Free Wheelchair Mission · May 2012
ZHENJIANG ASURE MECHANICAL WHEELCHAIR
K112816 · Zhenjiang Assure Medical Equipment Co., Ltd. · Apr 2012
REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM
K111636 · Gunnell, Inc. · Apr 2012
JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR
K112948 · Jiangsu Healthy Way Medical Equipment Co;Ltd · Mar 2012
JIANGSU HEALTHY WAY MECHANICL WHEELCHAIR
K112950 · Jiangsu Healthy Medical Equipment Co;Ltd · Mar 2012