The following data is part of a premarket notification filed by Thought Technology Ltd. with the FDA for Myonyx System.
| Device ID | K213197 |
| 510k Number | K213197 |
| Device Name: | MyOnyx System |
| Classification | Stimulator, Muscle, Powered |
| Applicant | Thought Technology Ltd. 5250 Ferrier, Suite 812 Montreal, CA H4P 1L3 |
| Contact | Suresh Sugirtharaja |
| Correspondent | Suresh Sugirtharaja Thought Technology Ltd. 5250 Ferrier, Suite 812 Montreal, CA H4P 1L3 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-29 |
| Decision Date | 2022-06-17 |