K251026
- 510(k) number
- K251026
- Device name
- Regenesis EMS Chair
- Applicant
- Trinity Medical Solutions AL · US
- Product code
- KPI — Stimulator, Electrical, Non-Implantable, For Inconti
- Decision date
- 2025-08-29
- Date received
- 2025-04-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251026.pdf
Official FDA record: K251026
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.