K250405
- 510(k) number
- K250405
- Device name
- Nerivio; Nerivio Infinity
- Applicant
- Theranica Bio-Electronics, Ltd. IL
- Product code
- QGT — Distal Transcutaneous Electrical Stimulator For Trea
- Decision date
- 2025-05-14
- Date received
- 2025-02-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K250405.pdf
Official FDA record: K250405
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.