FDA Registration
Active
🇺🇸 United States
Custom Ankle Foot Orthosis
Reg #: 1058152
·
FEI: 1000222089
·
Expires 2025
Products
1
Proprietary Names
17
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ORTHOMERICA PRODUCTS, INC.
- Registration Number
- 1058152
- FEI Number
- 1000222089
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 6333 N Orange Blossom Trl
- City
- ORLANDO
- State
- FL
- ZIP
- 32810
- Country
- US
Owner / Operator
- Firm Name
- ORTHOMERICA PRODUCTS, INC.
- Operator Number
- 9007946
- Address
- 6333 NORTH ORANGE BLOSSOM, TRAIL
- City
- Orlando
- State
- FL
- Postal Code
- 32810
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2006-10-25 |
Proprietary Names
Custom Ankle Foot Orthosis
Fuzion AFO
WHO Articulating Forefoot
WHO Midfoot
WHO Chopart
WHO Heel
WHO Forefoot
Shark-o
OWLS Lite
Spectrum
CrowWalker
TC Flex
Solid Ankle Shoe Insert
HealPRO
Spectrum Gauntlet
Fracture Brace Show Insert
Adjustable Single Axis Shoe Insert
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device