FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Regenesis EMS Chair
K Number: K251026
·
Decision Aug 29, 2025
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
95
Applicant Total
1
Review Days
149
Basic Information
- Device Name
- Regenesis EMS Chair
- K Number
- K251026
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5320
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trinity Medical Solutions
- Date Received
- April 2, 2025
- Decision Date
- August 29, 2025
- Product Code
- KPI
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | FDA class 2 | Gastroenterology, Urology |
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