The following data is part of a premarket notification filed by Broda Seating (broda Lp) with the FDA for Ikon 40 Manual Wheelchair.
| Device ID | K190550 |
| 510k Number | K190550 |
| Device Name: | IKON 40 Manual Wheelchair |
| Classification | Wheelchair, Mechanical |
| Applicant | Broda Seating (Broda LP) 560 Bingemans Centre Drive Kitchener, CA N2b3x9 |
| Contact | Jeremy Ballard |
| Correspondent | Jeremy Ballard Broda Seating (Broda LP) 560 Bingemans Centre Drive Kitchener, CA N2b3x9 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-05 |
| Decision Date | 2019-07-01 |