The following data is part of a premarket notification filed by Tri-tech, Inc. with the FDA for Gravitron Upper Body System Exerciser.
| Device ID | K912056 |
| 510k Number | K912056 |
| Device Name: | GRAVITRON UPPER BODY SYSTEM EXERCISER |
| Classification | Exerciser, Measuring |
| Applicant | TRI-TECH, INC. C/O RICHARD HAMER ASSOC.INC. P.O.BOX 16598 Fort Woth, TX 76162 |
| Contact | Richard A.hamer |
| Correspondent | Richard A.hamer TRI-TECH, INC. C/O RICHARD HAMER ASSOC.INC. P.O.BOX 16598 Fort Woth, TX 76162 |
| Product Code | ISD |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-09 |
| Decision Date | 1991-10-24 |