FDA Registration
Active
🇺🇸 United States
K-FIT KEGEL TONER, LLC
Reg #: 3014405438
·
FEI: 3014405438
·
Expires 2026
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- K-FIT KEGEL TONER, LLC
- Registration Number
- 3014405438
- FEI Number
- 3014405438
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2373 Cluster Oak Ave NW
- City
- Albany
- State
- OR
- ZIP
- 97321
- Country
- US
Regulatory Submissions
- 510(k) Number
- K163288
Owner / Operator
- Firm Name
- K-fit Kegel Toner, LLC
- Operator Number
- 10057321
- Address
- 2373 Cluster Oak Ave NW
- City
- Albany
- State
- OR
- Postal Code
- 97321
- Country
- US
- Correspondent
- Aimee Roseland
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | Class 2 | Gastroenterology, Urology | No | 2026-03-24 |
Proprietary Names
K-fit Kegel Toner
KM518
Establishment Types
Complaint File Establishment per 21 CFR 820.198