The following data is part of a premarket notification filed by Microcurrent Research, Inc. with the FDA for Acusource 600 (tens).
| Device ID | K895977 |
| 510k Number | K895977 |
| Device Name: | ACUSOURCE 600 (TENS) |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| 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 | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-12 |
| Decision Date | 1990-01-09 |