The following data is part of a premarket notification filed by Biowave Corporation with the FDA for Biowavego Rx.
| Device ID | K210202 |
| 510k Number | K210202 |
| Device Name: | BioWaveGO RX |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | BioWave Corporation 8 Knight Street, Suite 201 Norwalk, CT 06851 |
| Contact | Bradford Siff |
| Correspondent | Dave Mcgurl MCRA LLC 1050 K Street NW Suite 1000 Washington, DC 20001 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-25 |
| Decision Date | 2021-02-24 |