Regenesis EMS Chair— 510(k) K251026
Substantially EquivalentTrinity Medical Solutions
FDA 510(k) clearance K251026 for Regenesis EMS Chair, Substantially Equivalent on 2025-08-29. Applicant: Trinity Medical Solutions. Device class: 2.
Clearance details
- Applicant
- Trinity Medical Solutions
- Product code
- Code KPI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5320
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Birmingham, AL, US
Recent devices under product code KPI
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- K252831 — Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)
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Data sourced from openFDA. This site is unofficial and independent of the FDA.