K072123 is an FDA 510(k) clearance for the HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE. This device is classified as a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II - Special Controls, product code GZJ).
Submitted by Biowave Corporation (North Attleboro, US). The FDA issued a Cleared decision on February 1, 2008, 183 days after receiving the submission on August 2, 2007.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K072123 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2007 |
| Decision Date | February 01, 2008 |
| Days to Decision | 183 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZJ - Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |