FDA Registration
Active
🇩🇪 Germany
Footshell Runway Regular
Reg #: 9616494
·
FEI: 3003117657
·
Expires 2025
Products
1
Proprietary Names
128
Establishment Types
4
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 |
|---|---|---|---|---|---|
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 2005-07-28 |
Proprietary Names
Footshell Runway Regular
Bionic-Foot Footshell
Sliding Plate hole plate
Taleo
LP Symes
Taleo VS, Taleo Harmony
Freestyle Swim
Foot for water resistant prothesis
Tube-Adap,Short-34mm Steel
Tube Adapter f. water resist. Prothesis
Slide Adap. With 4 Screw Conn
Footshell Runway HX Regular
Greissinger plus foot
Connection Cap for 2C1 small
Sliding Adapter
Connection Cap
Modular Transtibial Kit
Axtion DP
ProSymes Prosthetic Foot
Single Axis Foot Adapter
Tube Adaptor, long, Aluminum
Trias
Single Axis Foot Only Men
Tube Adaptor,Long,Titan
Sole Kit 1E90 Sprinter - with Spikes
Sprinter
Dynamic foot with toes
SACH Foot
Bk Kit-34mm-Clamp-Steel
Tube Adapter, short, 34 mm, Titanium
Sliding Adaptor -Titanium-
Taleo Side Flex
Cosmetic Light Foot with Toes
Tube Adaptor,Short,Titan
Double Adaptor w. Screws
Footshell Runway Sandal
Runner
Footshell 1C40
Foot Adapter-Titan-
Slide Clamp-Alum
Socket Att.Block Mod.F.Ch
Runway HX
Spherical Sliding Adapter
DeltaTwist
Promenade
Terion
Shaped Ankle Block
Connection Adapter
Triton
SACH Foot,Child
Tube-Adapter, Children
Lo Rider
C-Walk
SACH plus Foot
Tube Adaptor Aluminium Short
Chopart
Triton Side Flex
SACH Foot,Child,Medium
Bk Kit-34mm-Clamp-Titanium
Foot Adapter
Double Adapter with Pyramid
Triton LP
Maverick VS
Anprobe-Sportadapter TT
Challenger
Foot Shell Gen2
Dynamic Ft,Women,20mm,Toes
SACH-foot
Tube Adapter, long, 34 mm, Titanium
Taleo Footshell
Foot Shell Gen3
Tube-Adap,Long-34mm-Steel
Sliding Adapter -Titanium-
ProCarve Foot Standard
Tube-Adapter, long
Trias Footshell
Otto Bock Dynamic Foot for children
Foot Adapter with thread
Runner Sole
Renegade AT
Sole Kit 1E90 Sprinter
Modular Transfemoral Kit
Axtion
Terion K2
Tube-Adapter, short
Evanto Footshell
Maverick Xtreme AT
Footshell for 1M10
Tube Clamp Adaptor, SS
Renegade LP-AT
Kintrol
TF Sports Foot Adapter
Footshell for 1C10
Tube Adaptor, Angled, Titan 10 -20 -30 degrees
Foots Shell Freestyle Swim
Complete bolt assembly
Evanto
Taleo Adjust
Meridium
Footshell Gen2 High
Foot Shell Kintrol
TF Test-Sportfootadapter
Tube Clamp Adaptor, Titan
Restore
Footshell-Child
Definitiv-Sportadapter TT
Footshell Runway HX Sandal
Triton Vertical Shock
Adjust
Tube Adapter, angled, Children
Defender
Runway
Tube Adaptor, angular 10 degrees, 20 degrees, 30 degrees, Titanium
Runner junior Pyramid Adapter, rotatable
Taleo LP
Runner junior
Single Axis Adapter
Tube Clamp Adaptor-Alum.
Dynamic Plus Prosthetic Foot Dynamic Motion Prosthetic Foot
Footshell ProSymes
Triton Harmony
Maverick Comfort AT
Pirogoff Foot
Triton HD
Maverick Footshell
Sprinter Junior
Maverick Junior Footshell
Maverick Junior
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device