Cleared Traditional

K152536 - MyOn HC Manual Wheelchair

K152536 is an FDA 510(k) clearance for MyOn HC Manual Wheelchair, manufactured by Invacare Corporation. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K152536 · Invacare Corporation · Physical Medicine device
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Jan 2016
Decision
123d
Days
Class 1
Risk

K152536 is an FDA 510(k) clearance for the MyOn HC Manual Wheelchair. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Invacare Corporation (Elyria, US). The FDA issued a Cleared decision on January 5, 2016 after a review of 123 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 Invacare Corporation devices

FDA 510(k) Submission Details - K152536

510(k) Number K152536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2015
Decision Date January 05, 2016
Days to Decision 123 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
8d slower than avg
Panel avg: 115d · This submission: 123d
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 235
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K152536.
Pure Tilt
K152021 · Proactive Comfort, LLC · Mar 2016
Weely Manual Wheelchair
K152827 · Rupiani · Feb 2016
SUNTEC Mechanical Wheelchair, model ST-WL-1000
K152878 · Danyang Suntec Auto Parts Co., Ltd. · Feb 2016
P.R.O. CG Manual Wheelchair
K151893 · Freedom Designs, Inc. · Oct 2015
Nuocande Plastic Manual Wheelchair Model NKD L07
K151797 · Ningbo Lecount Medical Technology Co., Ltd. · Aug 2015
Helio A7 Manual Wheelchair, Move Manual Wheelchair
K143101 · Motion Composites · May 2015