The following data is part of a premarket notification filed by Thought Technology Ltd. with the FDA for Myotrac2.
| Device ID | K915858 |
| 510k Number | K915858 |
| Device Name: | MYOTRAC2 |
| Classification | Device, Biofeedback |
| Applicant | THOUGHT TECHNOLOGY LTD. 2180 BELGRAVE AVE. Montreal, Quebec, CA H4a 2l8 |
| Contact | Hal K Myers |
| Correspondent | Hal K Myers THOUGHT TECHNOLOGY LTD. 2180 BELGRAVE AVE. Montreal, Quebec, CA H4a 2l8 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-27 |
| Decision Date | 1992-09-09 |