The following data is part of a premarket notification filed by Zimmer Elektromedizin Gmbh with the FDA for Galva-5-m.
| Device ID | K954411 |
| 510k Number | K954411 |
| Device Name: | GALVA-5-M |
| Classification | Stimulator, Muscle, Powered |
| 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 | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-21 |
| Decision Date | 1996-02-28 |