The following data is part of a premarket notification filed by Thought Technology Ltd. with the FDA for Myonyx System.
| Device ID | K201014 |
| 510k Number | K201014 |
| Device Name: | MyOnyx System |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | Thought Technology LTD. 5250 Ferrier, Suite 812 Montreal, CA H4p 1l3 |
| Contact | Zena Butris |
| Correspondent | Zena Butris Thought Technology LTD. 5250 Ferrier, Suite 812 Montreal, CA H4p 1l3 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-17 |
| Decision Date | 2021-01-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540191000616 | K201014 | 000 |
| 07540191000609 | K201014 | 000 |
| 07540191000593 | K201014 | 000 |
| 07540191000586 | K201014 | 000 |