Contract manufacturerPROTOSTHETICS (Fargo, ND)North DakotaPhysical medicineClass I
PROTOSTHETICS
Contract manufacturer · Fargo, ND
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3014820876 (openFDA record; or search FDA's registration database)
- FEI number
- 3014820876
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- Sapiyen LLC (FDA owner/operator no. 10082874)
- Registered address
- 510 6th Ave N, Suite D, Fargo, ND 58102
- Contract listings
- 4 device listings, 4 product codes, first listed Oct 10, 2021
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| IQI | Orthosis, Limb Brace | Class I | Physical medicine | Contract manufacturing | Oct 10, 2021 |
| IQO | Device, Prosthesis Alignment | Class I | Physical medicine | Contract manufacturing | Oct 10, 2021 |
| ISS | Prosthesis, Thigh Socket, External Component | Class I | Physical medicine | Contract manufacturing | Oct 10, 2021 |
| OHI | Orthosis, Foot Drop | Class I | Physical medicine | Contract manufacturing | Oct 10, 2021 |