FDA 510(k), K080950, STIWELL MED4
FDA 510(k), K080950, STIWELL MED4
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510(K) Number: K080950
Device Name: STIWELL MED4
Manufacturer: OTTO BOCK, AUSTRIA GMBH
Device Classification Name: Stimulator, Muscle, Powered
Regulation Number: 890.5850
Classification Product Code: IPF
Date Received: 04/03/2008
Decision Date: 04/02/2009
Regulation Medical Specialty: Physical Medicine
Device Name: STIWELL MED4
Manufacturer: OTTO BOCK, AUSTRIA GMBH
Device Classification Name: Stimulator, Muscle, Powered
Regulation Number: 890.5850
Classification Product Code: IPF
Date Received: 04/03/2008
Decision Date: 04/02/2009
Regulation Medical Specialty: Physical Medicine
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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