The following data is part of a premarket notification filed by Biowave Corporation with the FDA for Biowavehome Neuromodulation Pain Therapy Device.
| Device ID | K152437 |
| 510k Number | K152437 |
| Device Name: | BiowaveHOME Neuromodulation Pain Therapy Device |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | BIOWAVE CORPORATION 16 KNIGHT STREET Norwalk, CT 06851 |
| Contact | Bradford Siff |
| Correspondent | Bradford Siff BIOWAVE CORPORATION 16 KNIGHT STREET Norwalk, CT 06851 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-27 |
| Decision Date | 2015-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859911006072 | K152437 | 000 |