The following data is part of a premarket notification filed by Biowave Corporation with the FDA for Deepwave Neuromodulation Pain Therapy Device.
| Device ID | K052289 |
| 510k Number | K052289 |
| Device Name: | DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE |
| Classification | Interferential Current Therapy |
| Applicant | BIOWAVE CORPORATION 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane BIOWAVE CORPORATION 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | LIH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-23 |
| Decision Date | 2005-12-13 |
| Summary: | summary |