The following data is part of a premarket notification filed by Fortress Lite-style Wheelchairs, Inc. with the FDA for Vision (manual Wheelchair).
Device ID | K934234 |
510k Number | K934234 |
Device Name: | VISION (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 |