FDA Registration
Active
🇺🇸 United States
PROTOSTHETICS
Reg #: 3014820876
·
FEI: 3014820876
·
Expires 2026
Products
5
Proprietary Names
5
Establishment Types
2
Classifications
5
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Registration Details
- Registration Name
- PROTOSTHETICS
- Registration Number
- 3014820876
- FEI Number
- 3014820876
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 510 6th Ave N, Suite D
- City
- Fargo
- State
- ND
- ZIP
- 58102
- Country
- US
Owner / Operator
- Firm Name
- Sapiyen LLC
- Operator Number
- 10082874
- Address
- 510 6TH AVENUE N, SUITE D
- City
- Fargo
- State
- ND
- Postal Code
- 58102
- Country
- US
- Correspondent
- Darren Jacoby
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2023-01-20 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2021-10-10 |
| Prosthesis, Thigh Socket, External Component | ISS | Class 1 | Physical Medicine | No | 2021-10-10 |
| Orthosis, Foot Drop | OHI | Class 1 | Physical Medicine | No | 2021-10-10 |
| Device, Prosthesis Alignment | IQO | Class 1 | Physical Medicine | No | 2021-10-10 |
Proprietary Names
Protosthetics Orthotics
Dakota Brace
Amphibian Leg
Protosthetics Socket
Amphibian Water Leg
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)