BioWave BioWraps
FDA 510(k) K261522 · Biowave Corporation
510(k) numberK261522
Submission
- Device name
- BioWave BioWraps
- Applicant
- Biowave Corporation
Westport, CT, US - Received
- May 7, 2026
- Decision date
- June 3, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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More from Ceribell, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K203158 | BioWave BioWrapsGXY · Traditional | 07/08/2021SE |
| K210202 | BioWaveGO RXGZJ · Special | 02/24/2021SE |
| K180943 | BioWaveGOGZJ · Traditional | 08/17/2018SE |
| K152437 | BiowaveHOME Neuromodulation Pain Therapy DeviceGZJ · Special | 09/25/2015SE |
| K072123 | Homewave Neuromodulations Pain Therapy DeviceGZJ · Traditional | 02/01/2008SE |
| K061166 | Deepwave Percutaneous Neuromodulation Pain Therapy SystemNHI · Traditional | 08/15/2006SE |
| K052289 | Deepwave Neuromodulation Pain Therapy DeviceLIH · Traditional | 12/13/2005SE |
Questions and answers
When was BioWave BioWraps cleared by the FDA?
BioWave BioWraps (K261522) received a 510(k) decision of Substantially Equivalent on June 3, 2026, 27 days after the submission was received.
What is the product code of K261522?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.