K261522
- 510(k) number
- K261522
- Device name
- BioWave BioWraps
- Applicant
- Biowave Corporation CT · US
- Product code
- GXY — Electrode, Cutaneous
- Decision date
- 2026-06-03
- Date received
- 2026-05-07
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K261522.pdf
Official FDA record: K261522
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.