FDA Registration
Active
🇺🇸 United States
ORTHOTIC HOLDINGS INC.
Reg #: 3029785246
·
FEI: 3029785246
·
Expires 2026
Products
4
Proprietary Names
17
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- ORTHOTIC HOLDINGS INC.
- Registration Number
- 3029785246
- FEI Number
- 3029785246
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4825 East Ingram Street
- City
- Mesa
- State
- AZ
- ZIP
- 85205
- Country
- US
Owner / Operator
- Firm Name
- Orthotic Holdings Inc.
- Operator Number
- 10089075
- Address
- 4825 East Ingram Street
- City
- Mesa
- State
- AZ
- Postal Code
- 85205
- Country
- US
- Correspondent
- Ashley Grode
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Platform, Force-Measuring | KHX | Class 1 | Physical Medicine | No | 2023-11-03 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2023-12-06 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2023-11-03 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2023-12-06 |
Proprietary Names
Gaitscan
Pedalign Digital Scanner
Scan Cast 3D
Roomy Socks
Copper Cloud
Langer Biomechanics - Custom Orthotics
Apex - A-Wave
SafeStep - Custom Diabetic Inserts
Apex - Custom Diabetic Inserts
Langer Biomechanics - Custom Diabetic Inserts
Arizona AFO - Custom Ankle Foot Orthosis Brace
Pedalign Holdings - Custom Orthotics
Apex - Conform Insoles
The Orthotic Group - Custom Orthotics
Apex - Heat Molded Inserts
APEX
The Orthotic Group Footwear
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device