The following data is part of a premarket notification filed by Otto Bock, Austria Gmbh with the FDA for Stiwell Med4.
| Device ID | K080950 |
| 510k Number | K080950 |
| Device Name: | STIWELL MED4 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | OTTO BOCK, AUSTRIA GMBH 2247 JENNIFER LANE North St. Paul, MN 55109 -2851 |
| Contact | William F Jackson |
| Correspondent | William F Jackson OTTO BOCK, AUSTRIA GMBH 2247 JENNIFER LANE North St. Paul, MN 55109 -2851 |
| Product Code | IPF |
| Subsequent Product Code | GZI |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | HCC |
| Subsequent Product Code | KPI |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-03 |
| Decision Date | 2009-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04032767768776 | K080950 | 000 |
| 04032767648788 | K080950 | 000 |
| 04032767648795 | K080950 | 000 |
| 04032767648801 | K080950 | 000 |
| 04032767648818 | K080950 | 000 |
| 04032767648825 | K080950 | 000 |
| 04032767758081 | K080950 | 000 |
| 04032767759323 | K080950 | 000 |
| 04032767761401 | K080950 | 000 |
| 04032767767700 | K080950 | 000 |
| 04032767768714 | K080950 | 000 |
| 04032767768721 | K080950 | 000 |
| 04032767768738 | K080950 | 000 |
| 04032767768745 | K080950 | 000 |
| 04032767648771 | K080950 | 000 |