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 |