Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| External Trigger | 9001M01 | Otto Bock Healthcare Products GmbH | IPF | 04032767768738 |
| Stimulation Electrode Cable (Yellow) | 9001C02=4 | Otto Bock Healthcare Products GmbH | IPF | 04032767648818 |
| Stimulation Electrode Cable (green) | 9001C02=3 | Otto Bock Healthcare Products GmbH | IPF | 04032767648801 |
| STIWELL MED4 SUPPORT BASE | 9001M07 | Otto Bock Healthcare Products GmbH | IPF | 04032767758081 |
| Power Cable US version for Med4 | 9001C04=US | Otto Bock Healthcare Products GmbH | IPF | 04032767768714 |
| PC-Applications STIWELL med4 | 646C130=US-V1.2 | Otto Bock Healthcare Products GmbH | IPF | 04032767759323 |
| Stimulation Electrode Cable (orange) | 9001C02=2.3 | Otto Bock Healthcare Products GmbH | IPF | 04032767648795 |
| case sticker | 9001L05 | Otto Bock Healthcare Products GmbH | IPF | 04032767761401 |
| Case for Med4 kit | 642V16 | Otto Bock Healthcare Products GmbH | IPF | 04032767767700 |
| Carrying Clip for Med4 | 9001M03 | Otto Bock Healthcare Products GmbH | IPF | 04032767768745 |
| USB Cable for Med4 | 9001C05 | Otto Bock Healthcare Products GmbH | IPF | 04032767768721 |
| Reference Electrode Cable (Med4) | 9001C03 | Otto Bock Healthcare Products GmbH | IPF | 04032767648825 |
| Main Cable/Plug Med4 | 9001C01 | Otto Bock Healthcare Products GmbH | IPF | 04032767648771 |
| Stimulation Electrode Cable (Lilac) | 9001C02=11 | Otto Bock Healthcare Products GmbH | IPF | 04032767648788 |
| Charger for Med4 | 9001P01 | Otto Bock Healthcare Products GmbH | IPF | 04032767768776 |