FDA Registration
Active
🇺🇸 United States
Borze Inc AKIRA Electromagnetic Chair for Pelvic Floor Muscle Strengthening
Reg #: 3010395077
·
FEI: 3010395077
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- B'ORZE INC
- Registration Number
- 3010395077
- FEI Number
- 3010395077
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 950 W Bannock, Suite 100
- City
- Boise
- State
- ID
- ZIP
- 83702
- Country
- US
Regulatory Submissions
- 510(k) Number
- K230767
Owner / Operator
- Firm Name
- B'Orze Inc USA
- Operator Number
- 10046152
- Address
- 950 W Bannock Suite 1100
- City
- Boise
- State
- ID
- Postal Code
- 83702
- Country
- US
- Correspondent
- Rex Frazier
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | Class 2 | Gastroenterology, Urology | No | 2025-07-07 |
Proprietary Names
Borze Inc AKIRA Electromagnetic Chair for Pelvic Floor Muscle Strengthening
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility