The following data is part of a premarket notification filed by Fasstech with the FDA for Focus Emg.
Device ID | K940050 |
510k Number | K940050 |
Device Name: | FOCUS EMG |
Classification | Device, Biofeedback |
Applicant | FASSTECH 155 MIDDLESEX TURNPIKE Burlington, MA 01803 |
Contact | Lee Richard Brody |
Correspondent | Lee Richard Brody FASSTECH 155 MIDDLESEX TURNPIKE Burlington, MA 01803 |
Product Code | HCC |
CFR Regulation Number | 882.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-05 |
Decision Date | 1995-02-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() FOCUS EMG 85350303 4128177 Dead/Cancelled |
Teleemg, LLC 2011-06-20 |