The following data is part of a premarket notification filed by Elmed, Inc. with the FDA for Endodyne Dual.
| Device ID | K840321 |
| 510k Number | K840321 |
| Device Name: | ENDODYNE DUAL |
| Classification | Interferential Current Therapy |
| Applicant | ELMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LIH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-25 |
| Decision Date | 1984-03-16 |