The following data is part of a premarket notification filed by Myo-tronics Research, Inc. with the FDA for J4 Myo-monitor.
| Device ID | K842223 |
| 510k Number | K842223 |
| Device Name: | J4 MYO-MONITOR |
| Classification | Stimulator, Muscle, Powered, Dental |
| Applicant | MYO-TRONICS RESEARCH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Contact | Fray Adib |
| Correspondent | Fray Adib MYO-TRONICS RESEARCH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | NUW |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-05 |
| Decision Date | 1984-11-19 |