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FDA 510(k), K061166, DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM
FDA 510(k), K061166, DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM
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510(K) Number: K061166
Device Name: DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM
Manufacturer: BIOWAVE CORPORATION
Device Classification Name: stimulator, nerve, electrical, percutaneous (pens), for pain relief
Regulation Number: 882.5890
Classification Product Code: NHI
Date Received: 04/27/2006
Decision Date: 08/15/2006
Regulation Medical Specialty: Neurology
Device Name: DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM
Manufacturer: BIOWAVE CORPORATION
Device Classification Name: stimulator, nerve, electrical, percutaneous (pens), for pain relief
Regulation Number: 882.5890
Classification Product Code: NHI
Date Received: 04/27/2006
Decision Date: 08/15/2006
Regulation Medical Specialty: Neurology
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- 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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