The following data is part of a premarket notification filed by Fortress Scientific Ltd. with the FDA for Fortress 760-n 4 Wheel Power Wheelchair.
| Device ID | K921070 |
| 510k Number | K921070 |
| Device Name: | FORTRESS 760-N 4 WHEEL 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 | 1992-02-27 |
| Decision Date | 1992-05-26 |