The following data is part of a premarket notification filed by Broda Ent., Inc. with the FDA for Broda Model 587 Manual Wheelchair.
| Device ID | K032133 |
| 510k Number | K032133 |
| Device Name: | BRODA MODEL 587 MANUAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | BRODA ENT., INC. 385 PHILLIP ST. Waterloo Ontario, CA N2l 5r8 |
| Contact | Phillip Mctaggart |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-07-11 |
| Decision Date | 2003-07-21 |
| Summary: | summary |