The following data is part of a premarket notification filed by Fasstech with the FDA for Psi 220 Dual Emg.
| Device ID | K925197 |
| 510k Number | K925197 |
| Device Name: | PSI 220 DUAL EMG |
| Classification | Device, Biofeedback |
| Applicant | FASSTECH 155 MIDDLESEX TURNPIKE Burlington, MA 01803 |
| Contact | Richard Brody |
| Correspondent | 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 | 1992-10-15 |
| Decision Date | 1993-02-02 |