The following data is part of a premarket notification filed by Otto Bock Orthopedic Industry, Inc. with the FDA for Voyager/viper Wheelchair.
| Device ID | K000497 |
| 510k Number | K000497 |
| Device Name: | VOYAGER/VIPER WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | OTTO BOCK ORTHOPEDIC INDUSTRY, INC. 3000 XENIUM LANE, SUITE N Plymouth, MN 55441 |
| Contact | John Hendrickson |
| Correspondent | John Hendrickson OTTO BOCK ORTHOPEDIC INDUSTRY, INC. 3000 XENIUM LANE, SUITE N Plymouth, MN 55441 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-15 |
| Decision Date | 2000-03-08 |