The following data is part of a premarket notification filed by Otto Bock Orthopedic Industry, Inc. with the FDA for Raebbitt/evolution Powered Wheelchair.
| Device ID | K000678 |
| 510k Number | K000678 |
| Device Name: | RAEBBITT/EVOLUTION POWERED WHEELCHAIR |
| Classification | Wheelchair, Powered |
| Applicant | OTTO BOCK ORTHOPEDIC INDUSTRY, INC. 3000 XENIUM LANE, SUITE N Plymouth, MN 55441 |
| Contact | William Jackson |
| Correspondent | William Jackson OTTO BOCK ORTHOPEDIC INDUSTRY, INC. 3000 XENIUM LANE, SUITE N Plymouth, MN 55441 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-29 |
| Decision Date | 2000-09-18 |