The following data is part of a premarket notification filed by Biowave Corporation with the FDA for Biowave Biowraps.
| Device ID | K203158 |
| 510k Number | K203158 |
| Device Name: | BioWave BioWraps |
| Classification | Electrode, Cutaneous |
| 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 20005 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-22 |
| Decision Date | 2021-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859911006669 | K203158 | 000 |
| 00859911006249 | K203158 | 000 |
| 00859911006256 | K203158 | 000 |
| 00859911006461 | K203158 | 000 |
| 00859911006492 | K203158 | 000 |
| 00859911006508 | K203158 | 000 |
| 00859911006546 | K203158 | 000 |
| 00859911006560 | K203158 | 000 |
| 00859911006577 | K203158 | 000 |
| 00859911006584 | K203158 | 000 |
| 00859911006591 | K203158 | 000 |
| 00859911006607 | K203158 | 000 |
| 00859911006232 | K203158 | 000 |