The following data is part of a premarket notification filed by Rami International Corp. with the FDA for Galvanic Unit.
| Device ID | K790949 |
| 510k Number | K790949 |
| Device Name: | GALVANIC UNIT |
| Classification | Stimulator, Muscle, Diagnostic |
| Applicant | RAMI INTERNATIONAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ISB |
| CFR Regulation Number | 890.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-05-21 |
| Decision Date | 1979-08-16 |