The following data is part of a premarket notification filed by Broda Ent., Inc. with the FDA for Broda Wheelchair.
| Device ID | K905671 |
| 510k Number | K905671 |
| Device Name: | BRODA WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | BRODA ENT., INC. 72 VICTORIA ST. S., KITCHENER Ontario, Canada, CA N2g 2a9 |
| Contact | John Alldredge |
| Correspondent | John Alldredge BRODA ENT., INC. 72 VICTORIA ST. S., KITCHENER Ontario, Canada, CA N2g 2a9 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-18 |
| Decision Date | 1990-12-31 |