The following data is part of a premarket notification filed by Microcurrent Research, Inc. with the FDA for Acutron Multiwave For Use In Tmj Syndrome Pain Con.
| Device ID | K890143 |
| 510k Number | K890143 |
| Device Name: | ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON |
| Classification | Stimulator, Muscle, Powered, Dental |
| Applicant | MICROCURRENT RESEARCH, INC. 1440 WHALLEY AVE. STE 224 New Haven, CT 06515 |
| Contact | Paul Davis |
| Correspondent | Paul Davis MICROCURRENT RESEARCH, INC. 1440 WHALLEY AVE. STE 224 New Haven, CT 06515 |
| Product Code | NUW |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-13 |
| Decision Date | 1989-05-01 |