The following data is part of a premarket notification filed by Myofunctional Research Corp. Pty. Ltd. with the FDA for The Orthotrainer.
| Device ID | K924975 |
| 510k Number | K924975 |
| Device Name: | THE ORTHOTRAINER |
| Classification | Positioner, Tooth, Preformed |
| Applicant | MYOFUNCTIONAL RESEARCH CORP. PTY. LTD. P.O. BOX 14 Helensvale, Queensland, AU 4212 |
| Contact | Chris Farrell |
| Correspondent | Chris Farrell MYOFUNCTIONAL RESEARCH CORP. PTY. LTD. P.O. BOX 14 Helensvale, Queensland, AU 4212 |
| Product Code | KMY |
| CFR Regulation Number | 872.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-30 |
| Decision Date | 1993-07-08 |