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 |