The following data is part of a premarket notification filed by Zimmer Elektromedizin Gmbh with the FDA for Galva 5-t.
| Device ID | K960969 |
| 510k Number | K960969 |
| Device Name: | GALVA 5-T |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | ZIMMER ELEKTROMEDIZIN GMBH 9 JUNKERSSTRABE D7910 Neu-ulm, DE |
| Contact | Duchess Granger |
| Correspondent | Duchess Granger ZIMMER ELEKTROMEDIZIN GMBH 9 JUNKERSSTRABE D7910 Neu-ulm, DE |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-11 |
| Decision Date | 1996-05-15 |