K052289 is an FDA 510(k) clearance for the DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE. This device is classified as a Interferential Current Therapy (Class II - Special Controls, product code LIH).
Submitted by Biowave Corporation (North Attleboro, US). The FDA issued a Cleared decision on December 13, 2005, 112 days after receiving the submission on August 23, 2005.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K052289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2005 |
| Decision Date | December 13, 2005 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | LIH - Interferential Current Therapy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |