The following data is part of a premarket notification filed by Zimmer Medizinsystems Gmbh with the FDA for Soleoline, Soleo Stim, Soleo Sono, Soleo Sonostim.
| Device ID | K121059 |
| 510k Number | K121059 |
| Device Name: | SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | ZIMMER MEDIZINSYSTEMS GMBH JUNKERSSTRASSE 9 Neu-ulm, DE 89231 |
| Contact | Armin Petraschka |
| Correspondent | Alexander Schapovalov TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | IMG |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | IMI |
| Subsequent Product Code | IPF |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-04-06 |
| Decision Date | 2012-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053815003328 | K121059 | 000 |
| 04053815003311 | K121059 | 000 |
| 04053815003304 | K121059 | 000 |