FDA Registration
Active
🇨🇳 China
OTTO BOCK (CHINA) INDUSTRIES CO., LTD.
Reg #: 9611742
·
FEI: 3003117095
·
Expires 2026
Products
5
Proprietary Names
102
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- OTTO BOCK (CHINA) INDUSTRIES CO., LTD.
- Registration Number
- 9611742
- FEI Number
- 3003117095
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO. 3 GUANGYUAN DONG JIE, TONGZHOU INDUSTRY DEVELOPMENT AREA
- City
- BEIJING
- Country
- CN
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 |
|---|---|---|---|---|---|
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2005-07-28 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2005-07-28 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2005-09-26 |
| Components, Wheelchair | KNN | Class 1 | Physical Medicine | No | 2003-12-11 |
| Components, Exercise | IOD | Class 1 | Physical Medicine | No | 2013-05-22 |
Proprietary Names
FitKit WalkOn Lateral Junior
FitKit WalkOn Lateral
Heel wedges 10 degrees, 16 degrees, 22 degrees
X-ible flexible ankle joints
WalkOn Fit Kit
Mulfifunction correction system joints
WalkOn Flex Fit Kit
Dual Function Ankle Joint
Nexgear extension bars
Multifunctional system ankle joint
Infinity Air Walker, high
System-toe Pick-up Ank.Jt.
Malleo TriStep Ankle Orthosis
Ankle Support
Active Contour Ankle Joint
Dyna Ankle - Dynamic Ankle Orthosis
Concealed Spring Ankle Joint
WalkOn Trimable
Infinity Air Walker, low
Malleo Neurexa
System-Limit Mot Ankle Jt.
WalkOn Reaction
Malleo Sprint
WalkOn Reaction Fit Kit
WalkOn Reaction Plus Fit Kit
Carbon Ankle Seven
System Ankle Joint With Lam. Set
Walk On Flex
Malleo Immobil Night Splint
FitKit WalkOn Reaction Lateral
FitKit WalkOn Flex Junior
Nexgear Tango Ankle Joint
Nexgear side bar bilateral
GoOn
Achillo Sensa
WalkOn Reaction Plus, Junior
Malleo Sensa
Heel wedges 15 degrees, 30 degrees
Malleo Direxa Stirrup
Unilateral Ankle Joint
Walk-On AFO
Medial joint for correction joint
Reaction modul
Foot stirrup
WalkOn lateral
Nexgear lamination bar bilateral
WalkOn Reaction lateral
Malleo Neurexa pro
Heel Relief Orthosis Des. By Dr. Settner
Dorso Osteo Care Spinal Orthosis
Lumbo Direxa Stable
Lumbo Sensa, women
Spine Sport
Dosi EQ X
Multi 627, 631, 637
Lumbo Sensa
Lumbo Direxa Woman
Dorso Direxa Posture
Dorso Carezza Posture
Lumbo Carezza
Lumbo Direxa High
Dyneva
Dorso Direxa Basic
Dyneva light
Hyperextension orthosis
Hyperextension brace
Lumbo Tristep
Lumbo Direxa
Wristoform wrist support
Hallux Valgus ComfortT
Manu 3D
Correction adapter set
C-Brace Trial Orthosis
Foot Plates
ORTHOVALLEY AFO Solid Ankle
Ankle Joint -Stainl.Steel-
Manu 3D Basis
Stainless Steel Elbow Joint Bars
Acro ComforT
Shoulder Support
Epi Forsa Plus
Epi Sensa
Ankle Foot Orthosis
ORTHOVALLEY AFO Night Splint
ORTHOVALLEY AFO articulated
Malleo Immobil Air Walker, low
Hallux Valgus Combo ComfortT
Manu Comfort
Ankle Joint for Children
Manu 3D Pollex
Stainless Steel Elbow Joint Bar with Gable Lock
Manu Comfort Stable
Double Act. Ankle Jt. Child
Epiflex
Stainless Steel Elbow Joint Bar without Lock
ORTHOVALLEY Supramalleolar Orthosis
Syst. Positioning Joint
Thumboform Long
Malleo Immobil Air Walker, high
Omo Neurexa Plus
Various models
CPM pad kits
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)