# K190550: IKON 40 Manual Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: Broda Seating (Broda Lp)
- Decided: Jul 1, 2019 after 118 days
- Product code: IOR (Wheelchair, Mechanical)
- Device class: 1
- Regulation: 21 CFR 890.3850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K930803 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152536: MyOn HC Manual Wheelchair, Invacare Corporation (2016) Summary page 4.

## Indications for use
The standard IKON 40 is a manual wheelchair device that is intended to be used to provide mobility to persons ages 12 and over (adolescents and adults) with a weight capacity of 300 lbs. The device is to be used as a means of mobility for persons limited to a sitting position.

Source page: https://510kreport.com/device/K190550
Methodology: https://510kreport.com/methodology