ELITE ORTHOPAEDICS, INC.

FDA Device Registration & Listing · South El Monte, CA, US · Registration 2028810

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2028810
FEI Number
1000135616
Entity Name
ELITE ORTHOPAEDICS, INC.
City/State/Country
South El Monte, CA, US
Establishment Address
1535 SANTA ANITA AVE., South El Monte, CA 91733, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
ELITE ORTHOPAEDICS, INC. (Owner Number: 9006401)
Owner / Operator Contact Address
1535 Santa Anita Avenue, --, South El Monte, CA 91733, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Advantage II Walker Premiere Fracture Walker FS Air Walker FS Walker Premiere Pneumatic Fracture Walker Advantage I Walker Pediatric Fracture Walker Lace Up Ankle Brace Advantage I Pneumatic Walker AirVantage Pneumatic Walker Deluxe Lace Up Ankle Brace Advantage Ankle Foot Orthosis Air-Lite Stirrup Ankle Brace Memory Foam Stirrup Ankle Brace Revolve Hinged Ankle Brace Air-Gel Stirrup Ankle Brace Arm Sling Shoulder Abduction Sling 8" Memory Foam Universal Wrist Lacer 8" Memory Foam Universal Thumb Lacer 10" Memory Foam Wrist Splint 8" Memory Foam Thumb Spica 8" Memory Foam Wrist Splint Strapless Post Operative Shoe Square Toe Post Operative Shoe Open Heel Post Operative Shoe Mesh Top Post Operative Shoe

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 1995-09-20
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2009-02-03
ITC Stirrup, External Brace Component Physical Medicine Class 1 890.3410 2011-03-18
ILI Sling, Arm Physical Medicine Class 1 890.3640 2015-07-13
IQQ Joint, Shoulder, External Limb Component Physical Medicine Class 1 890.3420 2015-07-13
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2009-02-03
IPG Shoe, Cast Physical Medicine Class 1 890.3025 2009-02-03

Official Correspondent

Christine Chang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ELITE ORTHOPAEDICS, INC.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2028810. Last updated year: 2026. Please use registration number 2028810 when referencing this establishment in official correspondence.
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