The following data is part of a premarket notification filed by Fortress Scientific Ltd. with the FDA for Fortress Spirit Power Wheelchair.
Device ID | K900040 |
510k Number | K900040 |
Device Name: | FORTRESS SPIRIT POWER WHEELCHAIR |
Classification | Wheelchair, Powered |
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 | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-02 |
Decision Date | 1990-01-12 |