The following data is part of a premarket notification filed by Fortress Scientific Ltd. with the FDA for Fortress Buddy Front Wheel Drive Scooter.
| Device ID | K900042 |
| 510k Number | K900042 |
| Device Name: | FORTRESS BUDDY FRONT WHEEL DRIVE SCOOTER |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | FORTRESS SCIENTIFIC LTD. 1775 PENNSYLVANIA AVENUE, N.W. Washington, DC 20006 |
| Contact | Knable Gotts |
| Correspondent | Knable Gotts FORTRESS SCIENTIFIC LTD. 1775 PENNSYLVANIA AVENUE, N.W. Washington, DC 20006 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-02 |
| Decision Date | 1990-01-12 |