K061166 is an FDA 510(k) clearance for the DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM. This device is classified as a Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief (Class II - Special Controls, product code NHI).
Submitted by Biowave Corporation (North Attleboro, US). The FDA issued a Cleared decision on August 15, 2006, 110 days after receiving the submission on April 27, 2006.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890. Percutaneous Electrical Nerve Stimulator (pens) Is A Device Used For The Treatment Of Pain. Unlike The Classified Transcutaneous Electrical Nerve Stimulator That Apply An Electrical Current To Electrodes On A Patient's Skin To Deliver Stimulation, A Pens Uses Electrodes That Are Placed Percutaneously To Deliver Stimulation,.
| 510(k) Number | K061166 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2006 |
| Decision Date | August 15, 2006 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | NHI - Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |
| Definition | Percutaneous Electrical Nerve Stimulator (pens) Is A Device Used For The Treatment Of Pain. Unlike The Classified Transcutaneous Electrical Nerve Stimulator That Apply An Electrical Current To Electrodes On A Patient's Skin To Deliver Stimulation, A Pens Uses Electrodes That Are Placed Percutaneously To Deliver Stimulation, |