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
Phone
801 9746647

Products

Device Name Product Code
Joint, Elbow, External Limb Component, Powered IRE
Unit, Wrist, External Limb Component, Powered KGH
Hook, External Limb Component, Powered IQW
Valve, Prosthesis ISP
Orthosis, Limb Brace IQI
Unit, Wrist, External Limb Component, Mechanical ISZ
Cover, Limb IPM
Component, External, Limb, Ankle/Foot ISH
Electrode, Cutaneous GXY
Hand, External Limb Component, Powered IQZ
Joint, Elbow, External Limb Component, Mechanical IRD
Device, Prosthesis Alignment IQO
Joint, Knee, External Brace ITQ
Prosthesis, Thigh Socket, External Component ISS
Joint, Knee, External Limb Component ISY
Bandage, Cast ITG

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