The following data is part of a premarket notification filed by Microcurrent Research, Inc. with the FDA for Acutron Mentor Model 961.
| Device ID | K981976 |
| 510k Number | K981976 |
| Device Name: | ACUTRON MENTOR MODEL 961 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | MICROCURRENT RESEARCH, INC. 3810 EAST DESERT COVE AVE. Phoenix, AZ 85028 |
| Contact | Paul Davis |
| Correspondent | Paul Davis MICROCURRENT RESEARCH, INC. 3810 EAST DESERT COVE AVE. Phoenix, AZ 85028 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-01 |
| Decision Date | 1998-11-25 |
| Summary: | summary |