The following data is part of a premarket notification filed by Myotronics-noromed, Inc. with the FDA for Emg System.
| Device ID | K111687 |
| 510k Number | K111687 |
| Device Name: | EMG SYSTEM |
| Classification | Device, Biofeedback |
| Applicant | MYOTRONICS-NOROMED, INC. 5870 S. 194TH ST. Kent, WA 98032 -2126 |
| Contact | F. Adib |
| Correspondent | F. Adib MYOTRONICS-NOROMED, INC. 5870 S. 194TH ST. Kent, WA 98032 -2126 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-16 |
| Decision Date | 2011-09-29 |
| Summary: | summary |