FDA Registration
Active
🇺🇸 United States
Agilix F15 Foot
Reg #: 3004737223
·
FEI: 3004737223
·
Expires 2025
Products
1
Proprietary Names
22
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- PROTEOR USA, Gunnison
- Registration Number
- 3004737223
- FEI Number
- 3004737223
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 491 East 350 North
- City
- Gunnison
- State
- UT
- ZIP
- 84634
- Country
- US
Owner / Operator
- Firm Name
- PROTEOR USA
- Operator Number
- 10032353
- Address
- 1236 West Southern Avenue, Suite 101
- City
- Tempe
- State
- AZ
- Postal Code
- 85282
- Country
- US
- Correspondent
- Valery Barbour
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 2010-05-05 |
Proprietary Names
Agilix F15 Foot
Kinnex F14 Ankle and Foot
RUSH RAMPAGE, EVAQ8, LP & LP H2O Feet
Highlander FS3 Foot
Kinnex F14 Ankle
Kinterra RM3 Foot/Ankle
RUSH Kid Foot
Custom - Swim Foot (Contract Manufacturer)
RUSH ROGUE 2, EVAQ8 & H2O Foot
Foot Covering KEX
Foot Covering Without Fairing (Cap) Interface FTC
Pacifica FS2 and Pacifica LP FS4 Feet
DynAdapt F10 Foot
RUSH HiPro, HiPro EVAQ8 & HiPro H2O Feet
RUSH Chopart Foot
Renegade LP / AT Foot (Contract Manufacturer)
RUSH ROVER Foot
Foot Covering (Contract Manufacturing)
Foot Covering With Faiting (Cap) Interface FTF
Sierra FS1 Foot
DynaStep Foot; DynaTrek; Easy Run Blade; Gery Foot; SACH Foot; Single Axis Foot
Exalto Foot
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)