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 |