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 |