The following data is part of a premarket notification filed by Top End Wheelchair Sports, Inc. with the FDA for The Terminator.
| Device ID | K922535 |
| 510k Number | K922535 |
| Device Name: | THE TERMINATOR |
| Classification | Wheelchair, Mechanical |
| Applicant | TOP END WHEELCHAIR SPORTS, INC. 6551 44TH ST. NORTH, #5002 Pinellas Park, FL 34665 |
| Contact | Carol Peterson |
| Correspondent | Carol Peterson TOP END WHEELCHAIR SPORTS, INC. 6551 44TH ST. NORTH, #5002 Pinellas Park, FL 34665 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-28 |
| Decision Date | 1992-07-24 |