BioWaveGO
Stimulator, Nerve, Transcutaneous, For Pain Relief
Biowave Corporation
The following data is part of a premarket notification filed by Biowave Corporation with the FDA for Biowavego.
Pre-market Notification Details
| Device ID | K180943 |
| 510k Number | K180943 |
| Device Name: | BioWaveGO |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | Biowave Corporation 8 Knight Street, Suite 201 Norwalk, CT 06851 |
| Contact | Bradford Siff |
| Correspondent | Dave Mcgurl Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) 1050 K Street NW, Suite 1000 Washington, DC 20001 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-10 |
| Decision Date | 2018-08-17 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859911006010 | K180943 | 000 |
| 00859911006140 | K180943 | 000 |
Trademark Results [BioWaveGO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOWAVEGO 88350504 not registered Live/Pending |
BioWave Corporation 2019-03-21 |
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