The following data is part of a premarket notification filed by Thought Technology Ltd. with the FDA for Myotrac.
| Device ID | K881416 |
| 510k Number | K881416 |
| Device Name: | MYOTRAC |
| Classification | Device, Biofeedback |
| Applicant | THOUGHT TECHNOLOGY LTD. 2180 BELGRAVE AVE. Montreal, Quebec, CA H4a 2l8 |
| Contact | Hal D Myers |
| Correspondent | Hal D 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 | 1988-04-04 |
| Decision Date | 1988-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540191000227 | K881416 | 000 |
| 07540191000012 | K881416 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MYOTRAC 85260835 4086711 Live/Registered |
Myers Harold K 2011-03-08 |
![]() MYOTRAC 78340868 not registered Dead/Abandoned |
Thought Technology Ltd. 2003-12-15 |