The following data is part of a premarket notification filed by Fortress Lite-style Wheelchairs, Inc. with the FDA for Commuter (manual/power Wheelclhair).
Device ID | K934232 |
510k Number | K934232 |
Device Name: | COMMUTER (MANUAL/POWER WHEELCLHAIR) |
Classification | Wheelchair, Powered |
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 | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-19 |
Decision Date | 1994-03-29 |