FDA Registration
Active
🇩🇪 Germany
Dosi EQ X
Reg #: 9616494
·
FEI: 3003117657
·
Expires 2025
Products
1
Proprietary Names
19
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH
- Registration Number
- 9616494
- FEI Number
- 3003117657
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Max-Naeder-Strasse 15
- City
- DUDERSTADT Lower Saxony
- Country
- DE
Owner / Operator
- Firm Name
- Ottobock SE & Co. KGaA
- Operator Number
- 8010097
- Address
- Max-Naeder-Strasse 15
- City
- Duderstadt
- State
- Lower Saxony
- Postal Code
- 37115
- Country
- DE
US Agent
- Business Name
- Otto Bock HealthCare LP
- Contact Name
- Caleb Beck
- Address
- 3820 West Great Lakes Drive
- City
- Salt Lake City
- State
- UT
- ZIP
- 84120
- Country
- US
- [email protected]
- Phone
- 801 9746647
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2005-07-28 |
Proprietary Names
Dosi EQ X
Hyperextension brace
Multi 627, 631, 637
Dorso Direxa Posture
Lumbo Sensa
Lumbo Direxa Woman
Spine Sport
Dyneva
Dorso Carezza Posture
Dyneva light
Lumbo Tristep
Lumbo Carezza
Dorso Osteo Care Spinal Orthosis
Lumbo Direxa Stable
Hyperextension orthosis
Dorso Direxa Basic
Lumbo Direxa
Lumbo Sensa, women
Lumbo Direxa High
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device