FDA Registration
Active
🇦🇹 Austria
Malleo Immobil Air Walker, low
Reg #: 3005190268
·
FEI: 3005190268
·
Expires 2025
Products
1
Proprietary Names
31
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Otto Bock Healthcare Products GmbH
- Registration Number
- 3005190268
- FEI Number
- 3005190268
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Brehmstrasse 16
- City
- Vienna Wien
- Country
- AT
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, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2005-09-26 |
Proprietary Names
Malleo Immobil Air Walker, low
Ankle Foot Orthosis
Manu Comfort
Stainless Steel Elbow Joint Bar with Gable Lock
Wristoform wrist support
Epiflex
Hallux Valgus ComfortT
Manu 3D Pollex
Epi Forsa Plus
Ankle Joint for Children
Manu Comfort Stable
Double Act. Ankle Jt. Child
Acro ComforT
ORTHOVALLEY Supramalleolar Orthosis
Manu 3D
ORTHOVALLEY AFO articulated
Manu 3D Basis
Epi Sensa
Shoulder Support
Hallux Valgus Combo ComfortT
Correction adapter set
Thumboform Long
ORTHOVALLEY AFO Solid Ankle
Stainless Steel Elbow Joint Bars
Syst. Positioning Joint
Foot Plates
Ankle Joint -Stainl.Steel-
Malleo Immobil Air Walker, high
Omo Neurexa Plus
Stainless Steel Elbow Joint Bar without Lock
ORTHOVALLEY AFO Night Splint
Establishment Types
Manufacture Medical Device