The following data is part of a premarket notification filed by Fortress Lite-style Wheelchairs, Inc. with the FDA for Legend (manual Wheelchair).
| Device ID | K934236 |
| 510k Number | K934236 |
| Device Name: | LEGEND (MANUAL WHEELCHAIR) |
| Classification | Wheelchair, Mechanical |
| Applicant | FORTRESS LITE-STYLE WHEELCHAIRS, INC. 3000 K STREET, N.W., SUITE 500 Washington, DC 20007 |
| Contact | Ilene Knable Gotts |
| Correspondent | Ilene Knable Gotts FORTRESS LITE-STYLE WHEELCHAIRS, INC. 3000 K STREET, N.W., SUITE 500 Washington, DC 20007 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-19 |
| Decision Date | 1994-03-17 |