Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004737223

FEI Number

3004737223

Entity Name

PROTEOR USA, Gunnison

City/State/Country

Gunnison, UT, US

Establishment Address

491 East 350 North, Gunnison, UT 84634, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PROTEOR USA (Owner Number: 10032353)

Owner / Operator Contact Address

1236 West Southern Avenue, Suite 101, Tempe, AZ 85282, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Easy Run Blade SACH Foot Gery Foot Highlander Foot,FS3 PLIE 3 Knee, KD3 & KS3 Kinnex Ankle/Foot,F14 RUSH Kid Foot ACCESSORIES DynaTrek Ethos LP foot MALLEOLAR JUNCTION PLATE Sierra Foot,FS1 MULTIAXIS ANKLE SHAPED FOAM ANKLE RUSH HiPro; RUSH HiProEVAQ8; RUSH HiProH2O Feet Foot Covering with Faiting (Cap) Interface, FTF Agilix Foot,F15 Pacifica Foot,FS2 Foot Covering without Fairing (Cap) Interface, FTC RUSH Chopart Foot Single Axis Foot RUSH RAMPAGE; RUSH RAMPAGE EVAQ8; RUSH RAMPAGE LP; RUSH RAMPAGE LP H2O Feet RUSH ROGUE2; ROGUE2 EVAQ8; ROGUE2 H2O Feet DynaStep Foot Shockwave Foot Kinterra Foot/Ankle, RM3 DynAdapt Foot,F10 RUSH ROVER Foot Pacifica LP Foot,FS4, SYNSYS Leg Valve Pad bandage Cover for buckle Bandage Aflex ANKLE PRONG CONNECTOR AND DISH FOAM COVERING 4-AXIS KNEE Easy Ride BASE TUBE Trans-Femoral Rotator HyTrek THREAD CONNECTION ADAPTOR DISTAL LOCKING Proteor Quattro Microprocessor Knee SINGLE AXIS KNEE W/BRAKE FEMALE PYRAMID CONNECTOR Hydeal Knee CONNECTION ADAPTOR Matik Knee LOCKING KNEE COMPACT 4-AXIS KNEE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISH	Component, External, Limb, Ankle/Foot	Physical Medicine	Class 1	890.3420	2010-05-05
ISW	Assembly, Knee/Shank/Ankle/Foot, External	Physical Medicine	Class 2	890.3500	2023-02-20
ISP	Valve, Prosthesis	Physical Medicine	Class 1	890.3420	2021-06-17
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2019-01-31
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2019-01-31
ISY	Joint, Knee, External Limb Component	Physical Medicine	Class 1	890.3420	2019-01-31

Official Correspondent

Valery Barbour

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PROTEOR USA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008584163	PROTEOR USA	Tempe, AZ, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004737223. Last updated year: 2026. Please use registration number 3004737223 when referencing this establishment in official correspondence.