The following data is part of a premarket notification filed by Thought Technology Ltd. with the FDA for Myodac2 Biofeedback Device.
| Device ID | K894840 |
| 510k Number | K894840 |
| Device Name: | MYODAC2 BIOFEEDBACK DEVICE |
| 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 | 1989-07-20 |
| Decision Date | 1989-10-13 |