FDA Registration
Active
🇺🇸 United States
ELITE ORTHOPAEDICS, INC.
Reg #: 2028810
·
FEI: 1000135616
·
Expires 2026
Products
10
Proprietary Names
37
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- ELITE ORTHOPAEDICS, INC.
- Registration Number
- 2028810
- FEI Number
- 1000135616
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1535 SANTA ANITA AVE.
- City
- South El Monte
- State
- CA
- ZIP
- 91733
- Country
- US
Owner / Operator
- Firm Name
- ELITE ORTHOPAEDICS, INC.
- Operator Number
- 9006401
- Address
- 1535 Santa Anita Avenue, --
- City
- South El Monte
- State
- CA
- Postal Code
- 91733
- Country
- US
- Correspondent
- Christine - Chang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 1995-09-20 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2009-02-03 |
| Stirrup, External Brace Component | ITC | Class 1 | Physical Medicine | No | 2011-03-18 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2015-07-13 |
| Joint, Shoulder, External Limb Component | IQQ | Class 1 | Physical Medicine | No | 2015-07-13 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2009-02-03 |
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2009-02-03 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2009-02-03 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2011-08-08 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2009-02-03 |
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
Ankle Foot Orthosis
Premiere Adjustable Night Splint
Adjustable Night Splint
Dorsal Night Splint
Post Operative Range of Motion Knee Brace - Light
Post Operative Range of Motion Knee Brace
Range of Motion Hinged Knee Wrap
Neoprene Hinged Knee Wrap
Neoprene Hinged Knee Sleeve
Advantage Tri-Panel Knee Immobilizer
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device