The following data is part of a premarket notification filed by Otto Bock Health Care, Lp with the FDA for Bravoracer Pediatric Manual Wheelchair.
| Device ID | K082314 |
| 510k Number | K082314 |
| Device Name: | BRAVORACER PEDIATRIC MANUAL WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | OTTO BOCK HEALTH CARE, LP 2247 JENNIFER LANE St Paul, MN 55109 |
| Contact | William Jackson |
| Correspondent | William Jackson OTTO BOCK HEALTH CARE, LP 2247 JENNIFER LANE St Paul, MN 55109 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-13 |
| Decision Date | 2008-10-28 |
| Summary: | summary |