The following data is part of a premarket notification filed by Fortress Scientific Ltd. with the FDA for Fortress 1704fs Four Wheel Scooter.
Device ID | K922966 |
510k Number | K922966 |
Device Name: | FORTRESS 1704FS FOUR WHEEL 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 | 1992-06-19 |
Decision Date | 1992-08-03 |