Cleared Traditional

K190550 - IKON 40 Manual Wheelchair

K190550 is an FDA 510(k) clearance for IKON 40 Manual Wheelchair, manufactured by Broda Seating (Broda Lp). The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K190550 · Broda Seating (Broda Lp) · Physical Medicine device
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Jul 2019
Decision
118d
Days
Class 1
Risk

K190550 is an FDA 510(k) clearance for the IKON 40 Manual Wheelchair. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Broda Seating (Broda Lp) (Kitchener, CA). The FDA issued a Cleared decision on July 1, 2019 after a review of 118 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 Broda Seating (Broda Lp) devices

FDA 510(k) Submission Details - K190550

510(k) Number K190550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2019
Decision Date July 01, 2019
Days to Decision 118 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
3d slower than avg
Panel avg: 115d · This submission: 118d
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 K190550.
Manual Wheelchair, Model A011
K201461 · Ningbo Shenyu Medical Equipment Co.,Ltd · May 2021
RGK Daily Range Wheelchairs
K200135 · Rgk Wheelchairs, Ltd. · Sep 2020
Manual Wheelchair
K192658 · Jerry Medical Instrument (Shanghai) Co., Ltd. · Apr 2020
Manual Wheelchair SIVFH2A102
K190534 · Jiangsu Horizon Medical Science & Technology Co., Ltd. · May 2019
Rowheels Revolution 1.0
K190699 · Rowheels, Inc. · May 2019
Manual Wheelchair W54
K180309 · Jiangsu Jumao Medical Equipment Co., Ltd. · May 2019