K243131
- 510(k) number
- K243131
- Device name
- Triathlon Pro
- Applicant
- Sigma Biomedical FL · US
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2025-11-07
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K243131.pdf
Official FDA record: K243131
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.