FDA Registration
Active
🇦🇹 Austria
Otto Bock Healthcare Products GmbH
Reg #: 3005190268
·
FEI: 3005190268
·
Expires 2026
Products
16
Proprietary Names
550
Establishment Types
1
Classifications
16
Registration Details
- Registration Name
- Otto Bock Healthcare Products GmbH
- Registration Number
- 3005190268
- FEI Number
- 3005190268
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Brehmstrasse 16
- City
- Vienna Wien
- Country
- AT
Regulatory Submissions
- 510(k) Number
- K123795
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, Elbow, External Limb Component, Powered | IRE | Class 1 | Physical Medicine | No | 2005-09-26 |
| Unit, Wrist, External Limb Component, Powered | KGH | Class 1 | Physical Medicine | No | 2005-09-26 |
| Hook, External Limb Component, Powered | IQW | Class 1 | Physical Medicine | No | 2016-07-05 |
| Valve, Prosthesis | ISP | Class 1 | Physical Medicine | No | 2014-11-03 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2005-09-26 |
| Unit, Wrist, External Limb Component, Mechanical | ISZ | Class 1 | Physical Medicine | No | 2012-09-13 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2014-08-04 |
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 2005-07-28 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2014-08-06 |
| Hand, External Limb Component, Powered | IQZ | Class 1 | Physical Medicine | No | 2014-08-06 |
| Joint, Elbow, External Limb Component, Mechanical | IRD | Class 1 | Physical Medicine | No | 2004-12-29 |
| Device, Prosthesis Alignment | IQO | Class 1 | Physical Medicine | No | 2014-11-03 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2014-05-05 |
| Prosthesis, Thigh Socket, External Component | ISS | Class 1 | Physical Medicine | No | 2005-05-12 |
| Joint, Knee, External Limb Component | ISY | Class 1 | Physical Medicine | No | 2005-07-28 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2016-07-14 |
Proprietary Names
4-Step Transducer
Linear Transducer
DynamicArm Plus
Cable Pull Switch
Rocker Switch
AnalogAdapter
Harness Pull Switch
Manu Carezza
ErgoArm Electronic plus
Manu Junior
Rhizo Arexa
Manu Arexa
DynamicArm
Pressure Switch
Manu Sensa wrist support, skin color
Manu Arexa Pollex
Manu Junior Pollex
MyoRotronic
AxonRotation
Electric Wrist Rotator
AxonHook
Threaded Valve With Housing
Valve for Flexible Socket
Vacuum connector
Tube Valve for Suction Socket
Harmony P3
One-way valve
Harmony P4 HD
Flat Rubber Valve
ClickValve
Mag Valve
Valve for Isny Socket
Push Valve
Harmony P4 Vacuum Pump
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
Wrist Unit - ratchet type rotation, short
Adaptor for 10V39
Otto Bock Friction Wrist Unit
Wrist Unit - Ratchet Type Rotation
wrist.transcarpal
MyoWrist Transcarpal
wrist.short
wrist.flex
wrist.eqd
Endoskeletal Adapter
MySkin Move
Genium X3 Protective Cover
Triton Footshell
Bebionic skin silicone black
Derma Seal Trans Ped
iconiq
Soft Touch
Kenevo Protective Cover
Connection Plate
Myo prosthetic Skin Natural gloves for adolescents and women
Prosthetic Skin Natural gloves for children
AK Prosthetic Shrinker
Caleo 3D
mHand Skin
michelangelo glove for women
Special Pros.Sock for Liner, Terry Cloth
Functional knee part
michelangelo glove translucent / black
Prosthetic Sock - Plain Knit
Functional cosmesis Genium X4
Cosmetic foam cover for hip ex.
SKEO 3D
Genium X4 Protective cover, short
Prosthetic Skin Natural gloves for adolescents
Compression Liner Cushion
Myo prosthetic gloves for women
Prosthetic gloves for women
Prosthetic Sock dis. Terry-prox. Cotton
Compression Liner Locking
Myo prosthetic Skin Natural gloves for women
Harmony Taper Sleeve
SKEO 3D TT
Skeo Sealing
michelangelo glove for men
Special Prosth. Sock for Ob Liner, Nylon
Functional stocking
Foam Cover, AK
Custom Sleeve
Skeo 3D
bebionic Silicone Glove
C-Leg Protective Cover w/o shield
Gaitor Sleeve
Foam Cover
Prosthetic Skin Natural gloves for women
Functional Cosmesis C-Leg
Uneo
AxonSkin Silicone Glove
Prosthetic Sock, BK, Wool
Thigh kit/Magnetic closure
Harmony Sleeve
Skeo Skinguard
Sticky Spot, Brim Pad Sticky Cover
Functional Cosmesis Genium
Uneo, Uneo Skinguard
Myo prosthetic gloves for children
Physio inner hands for men
Compression Shrinker for transfem.amp.CCL1
Functional Cosmesis Genium (Knee Part)
Liner Dynamic Vacuum System
Skeo up Daily Assist
AeroLink Hybrid Liner
Cosmetic Foam Cover
ProSeal SIL Liner
Pre-Shaped, Cored, Flexed AK Cover
AK Adapt Liner
Skeo Pure
Myo prosthetic gloves for adolescents and men
Myo prosthetic gloves for adolescents and women
Prosthetic gloves for children
BK Prosthetic Shrinker
Caleo
Genium X4 Protective cover, long
Skeo Unique
Silicon Gel Liner
Bebionic skin silicone
Derma Seal Double forte
Uneo 3D, Fresh
Skeo Unique Liner
Myo prosthetic Skin Natural gloves for children
Physio inner hands for women
Compression Shrinker for transtib.amp.CCL1
C-Leg Guard
Skeo Sealing TT
Skeo Sealing 3D
Functional Stocking
Cosmetic foam cover
Physio inner hands for children
Prosth. Sock, Terry Cloth
Shield insert
Footshell 1C30
Uneo Unique Custom Liner
Foam Cover, pediatric BK, TT
Uneo Flex Liner
Foam Cover, Tibial-square
MySkin Myo
Prosthetic Sock dis. Cotton-prox. Terry
C-Leg Protector
Foot Cosmetics
Liner fit kit
Functional Cosmesis C-Leg (Knee Part)
Uneo Skinguard
Prosthetic gloves for adolescents and men
Skeo
Myo prosthetic Skin Natural gloves for men
Tube-Adap,Short-34mm Steel
Definitiv-Sportadapter TT
Sliding Adapter
ProCarve Foot Standard
Tube-Adapter, Children
Double Adaptor w. Screws
Sprinter
Terion K2
Adjust
Taleo Side Flex
Renegade AT
Foot for water resistant prothesis
Tube-Adap,Long-34mm-Steel
Meridium
Runner
Footshell for 1M10
Foot Adapter-Titan-
Anprobe-Sportadapter TT
Kintrol
Bionic-Foot Footshell
Sliding Adapter -Titanium-
Maverick VS
Connection Cap
Trias Footshell
Footshell Gen2 High
Tube Adapter, long, 34 mm, Titanium
TF Test-Sportfootadapter
Sliding Plate hole plate
Dynamic Plus Prosthetic Foot Dynamic Motion Prosthetic Foot
Tube-Adapter, short
Tube Adaptor Aluminium Short
Shaped Ankle Block
Tube Adaptor, long, Aluminum
Spherical Sliding Adapter
Runway HX
Triton Side Flex
Tube Adaptor, angular 10 degrees, 20 degrees, 30 degrees, Titanium
Runway
C-Walk
Sprinter Junior
Defender
Foot Adapter with thread
Tube Clamp Adaptor-Alum.
Terion
SACH Foot,Child
Complete bolt assembly
Axtion
Triton Vertical Shock
Cosmetic Light Foot with Toes
Tube Adapter f. water resist. Prothesis
DeltaTwist
Runner junior
Tube Adapter, angled, Children
Connection Adapter
Challenger
Pirogoff Foot
Lo Rider
Triton LP
Bk Kit-34mm-Clamp-Titanium
Tube Adapter, short, 34 mm, Titanium
TF Sports Foot Adapter
Socket Att.Block Mod.F.Ch
Dynamic Ft,Women,20mm,Toes
Footshell 1C40
Runner Sole
Maverick Comfort AT
Maverick Junior
Foot Shell Gen2
Single Axis Adapter
Runner junior Pyramid Adapter, rotatable
Foot Shell Kintrol
Maverick Junior Footshell
LP Symes
Footshell Runway HX Sandal
Tube Adaptor,Short,Titan
Tube Clamp Adaptor, Titan
Restore
Single Axis Foot Only Men
Tube Adaptor,Long,Titan
Tube Adaptor, Angled, Titan 10 -20 -30 degrees
Greissinger plus foot
Otto Bock Dynamic Foot for children
Evanto
Bk Kit-34mm-Clamp-Steel
Foot Shell Gen3
Footshell Runway Regular
Single Axis Foot Adapter
Foot Adapter
Modular Transfemoral Kit
Slide Clamp-Alum
Footshell Runway Sandal
Dynamic foot with toes
Connection Cap for 2C1 small
Slide Adap. With 4 Screw Conn
Maverick Footshell
ProSymes Prosthetic Foot
Double Adapter with Pyramid
Taleo
SACH plus Foot
Evanto Footshell
Modular Transtibial Kit
Freestyle Swim
Footshell Runway HX Regular
Footshell ProSymes
Sole Kit 1E90 Sprinter - with Spikes
Triton
Maverick Xtreme AT
Footshell-Child
Tube-Adapter, long
Tube Clamp Adapter
Foots Shell Freestyle Swim
Promenade
Taleo Adjust
Chopart
Triton HD
Footshell for 1C10
Trias
Renegade LP-AT
Taleo LP
SACH-foot
Sole Kit 1E90 Sprinter
Axtion DP
Triton Harmony
Sliding Adaptor -Titanium-
Taleo Footshell
SACH Foot,Child,Medium
Taleo VS, Taleo Harmony
SACH Foot
Axon-Bus Prosthetic System
Axon-Bus Prosthetic System Service, Test
AxonRotation Adapter
Suction Socket Electrode
AxonEnergy Integral
AxonSoft 2.2
Michelangelo Hand
Electrode
AxonArm Ergo
Michelangelo Hand Transcarpal
AxonCharge Integral
AxonMaster
Modular Elbow Joint
MovolineArm Friction
ErgoArm Plus
Lock Set
ErgoArm Hybrid Plus
Modular Kit Shoulder Disarticulation
Modular Kit Transhumeral
Elbow Set-Up
ErgoArm
Elbow Set-Up for Children
myosmart.
connectgrip.
myosmart trial kit
myosmart.cuff
ElbowSoft TMR 1.4
Harmony P4 modular HD
Otto Bock Silicone ArmLiner
bebalance+ 1.6
ProFlex Plus short
MyolinoLink
Harmony P4 modular
PAULA 1.2
M-Soft 1.4
Derma ProFlex
Derma Protection ArmComfort
C-Soft 2.8
X-Soft 1.10
MyoBoy
Neoprene AK Suspension
K-Soft 1.6
Derma Protection Knee Comfort
C-Soft Plus 1.10
ProFlex Plus
ElbowSoft 1.6
Sliding Adapter Set
connectgo.pro
Support Bandage
Ak Suspension
Derma ProFlex short
MyolinoSoft
Syst.Cov.Bale Lock Jt.Hd.
Swiss Lock Knee Joint for Child
Lock lever extender for 17KL100
Medial Support for E-Mag Active
Lim.Mot.Knee Joint f.Child
Genu Direxa
Syst.-Adj.Swiss Lock Knee Joint
Syst.Ring Lock Joint Head
E-Mag active
Genu Immobil Vario T
Genu Direxa Stable wraparound
System Ring Lock Joint Head
Free Mot. Kn.Jt.for Child.
Genu Neurexa
DTO - Diagnostic Trial Orthosis
Posterior Off Set Free Knee Joint
Xeleton
Syst.-Free Motion Jt. Head
Ring Lock Knee Joint for Child
Genu Immobil
Agilium SoftFit
Knee Joints
Manual Ring Lock Knee Joint
Automatic Heavy Ring Lock Knee Joint
Agilium Reactive
Agilium Vantage
Knee Joint f.Wood Prosth.
Sys.-Cov.Bale Lock Jt.Hd.
Genu Carezza Patella Stabilizer
Genu Sensa
Genu Direxa wraparound
Syst.-Free Motion Jt.Head
Patella Pro
System-Covered Bale Lock Knee Joint
Free Walk Orthoses
Genu Direxa Stable
System Knee Joint
Plastic Polyc. Knee Joint
Agilium Patella
Free Motion Knee Joint
Knee Joint f.Plast.Prosth.
Syst.-Cov.Bale Lock Jt. Hd
Manual Heavy Ring Lock Knee Joint
C-Brace joint unit
Knee joint bar
Syst.-Cable Release Jt.Hd.
Bow ,Chailey Kit
C-Brace Setup
Knee Orthosis Genu Arexa
System Knee Joint with Lamination Set
Bale Lock Knee Joint
Knee Joint
Agilium Freestep
Automatic Ring Lock Knee Joint
Agilium Forte
System Wedge Lock Knee Joint Titanium
Ring Lock Kn.Jt.for Child
Bar Lock Knee Joint
Polycentric Knee Joint
4-1 Option Lock Knee Joint
Knee Bearing Joint
Syst.-Polycentric Jt. Head
System Electric Hand Digital Twin
Interchangeable Battery
Pulse Battery Charger
MyoHand VariPlus Speed
Electric Hand 2000
System Electric Greifer DMC VariPlus
bebionic Hand Short Wrist
bebionic Hand EQD
Transcarpal Hand DMC plus
SensorHand Speed
SensorHand Speed Flex
MyoEnergy Integral
7in1 Controller
speed.hand
MyoCharge Integral
System Electric Hand DMC Plus
EnergyPack
X-ChangePack
bebionic Hand Flex
Socket Adapter - titanium -
B.K. Socket Adapter-Titanium
Socket Adaptor w. Adjustment Screws
Klima-Arm Liner
Knee Cap, reinforced
Derma Seal forte
Varos Liner
Eingussanker, gew. Arm, JK
Socket Adaptor with Rotation Pyramid
Lamination Anchor
Sock.Adpt. , Adjust.Screws
Derma Seal Gel Socks
Rotatable Sock.Adapt.Titan
Lamination Ring up to 150 kg
Socket Adapter - aluminium -
Two-Directional Rubber Knee Cap
Sock.Adapt.With Pyramid Titan
Socket attachment block for thermoplast socket
Sock.Adapt.With Adjust.Screws
ProSeal Ring
Socket Adapter w. Pyramid
Socket Attachment Block
Socket Adapt.with Pyramid
Dynamic Vacuum System
System-Extension Assist
Socket Adaptor-Aluminum
MagnoFlex Lock
Shuttle Lock
Double Adapter
Rotatable 4 prong Adapter with adj screws
Varos
Lamination Anchor with angled arm
Socket Adapter w. Rotation Adjustment
lam. Anchor f. water resist. Prothesis
Rotatable 4 prong Adapter with Pyramid
Socket Adaptor-Child
Socket Adapter
Tube Clamp Adaptor
Rotatable Socket Adaptor
Myo Plus trial kit
Myo Plus
Myo Plus TR
Remote Electrode
Myo Cuff
connectgo
Lamination anchor for children
AXON Tube Adapter
Modular knee joints
Eccentric Adapter -titanium -
Polycntr. Knee for KD, Lock,Titan.
Polycntr. Knee Joint for KD, Lock
Tube Adapter with torsion unit, 34 mm
Genium
ProCarve knee joint
Lock Lever
Single Axis Knee Joint, Break Titan.
USB Adapter for charging
Modular Knee Joint, pneumatic
Knee Joint Children, Lock
Modular Friction Brake Knee Joint with Lock
Modular Kneejoint, monocentric with hydraulic rotation and electrically controlled stand phase
Single Axis Knee Joint Children
Comfort Brake Knee pneumatic system
Modular EBS Knee Joints
Single Axis Knee Joint, Break
Modular Knee Joint
Modular Sports Knee Joint
Prosedo
C-Leg Tube Adapter with Torsion Unit
Tube Clamp Adapter 34, INOX
Mod. Polycentric Knee Joint
Quickchange
Genium X3
Torsion Adapter
Polycntr. Knee Joint for KD
Sliding adapter
Kenevo
Rotation Adapter
Cockpit
Adapter Plate
C-Leg
dynion explore
Polycntr. Knee Joint for KD, Titan.
AXON Tube Adapter with Torsion
EBS-PRO-Knee
Harmony E2
Battery Charger for C-Leg
Tube Clamp Adapter 34, Titan
Inductive Charger
Single Axis Knee Joint, Lock
Aqua Knee
C-leg Tube Adapter
Dynion
Pyramid Adaptor with Internal Thread
Children's knee joint
Adapter Plate Harmony E2
Modular Knee Joint, servo-pneumatic
Lightweight Knee Joint, Lock
Lightweight Hydraulic Knee
Pheon - Modular Knee Joint
Polycntric Knee Joint, Children
Genium X4
Single Axis Knee Joint, Lock, Titan.
Polycntr. Hydr. Knee Joint, Titan.
Modular Knee Joint with Rotary Hydraulic
Adapter Ring
Kenevo A-B-C
Polycntr. Knee Joint, Titan.
Transhumeral Soft Harness
Establishment Types
Manufacture Medical Device