FDA Registration Active 🇩🇪 Germany

Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH

Reg #: 9616494 · FEI: 3003117657 · Expires 2026
Products
39
Proprietary Names
777
Establishment Types
4
Classifications
39

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
2026
Initial Importer
No
Address
Max-Naeder-Strasse 15
City
DUDERSTADT Lower Saxony
Country
DE

Regulatory Submissions

510(k) Number
K253256

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
Valve, Prosthesis ISP
Joint, Elbow, External Limb Component, Mechanical IRD
Cane IPS
Joint, Shoulder, External Limb Component IQQ
Orthosis, Lumbo-Sacral IPY
Orthosis, Cervical IQK
Hand, External Limb Component, Powered IQZ
Electrode, Cutaneous GXY
Hook, External Limb Component, Mechanical IQX
Orthosis, Truncal/Orthosis, Limb MRI
Platform, Force-Measuring KHX
Splint, Hand, And Components ILH
Orthosis, Thoracic IPT
Orthosis, Corrective Shoe KNP
Hand, External Limb Component, Mechanical IRA
Unit, Wrist, External Limb Component, Powered KGH
Unit, Wrist, External Limb Component, Mechanical ISZ
Goniometer, Ac-Powered KQX
Hook, External Limb Component, Powered IQW
Support, Hernia EXN
Cover, Limb IPM
Device, Prosthesis Alignment IQO
Joint, Ankle, External Brace ITW
Sling, Arm, Overhead Supported ILE
Band Or Belt, Pelvic Support ISR
Orthosis, Limb Brace IQI
Prosthesis, Thigh Socket, External Component ISS
Crutch IPR
Joint, Hip, External Brace ITS
Bandage, Cast ITG
Joint, Knee, External Brace ITQ
Support, Arm IOY
Stirrup, External Brace Component ITC
Orthosis, Sacroiliac, Soft IPW
Joint, Knee, External Limb Component ISY
Joint, Elbow, External Limb Component, Powered IRE
Joint, Hip, External Limb Component ISL
Orthosis, Lumbar IQE
Component, External, Limb, Ankle/Foot ISH

Proprietary Names

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 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 Forearm Crutches MovoShoulder Swing Otto Bock Shoulder Joint Otto Bock Ball Shoulder Joint Passport LSO Smartspine LSO Standard Ottobock Fulcrum LSO Low Profile LSO Lite MAC Standard Comprehensive LSO Smartspine LSO Low Original 10 inch Standard Option 1, Option 2, Option 3 Low Profile LSO Pathway LS Smartspine TLSO Premium Plus Low-Profile Cybertech S.P.I.N.E. Brace Original Cybertech Low Pro 8 inch Cyber 8 inch Low-Profile LSO Dosi EQ X High SI Belt Low-Profile Mini Minerva Orthosis Cervical Immobilizer Necky Color Forte Cervical Orthoses Cyberspine Cervical Orthosis Smartspine Universal Collar Minerva Necky Color Cervical Orthoses myosmart. connectgrip. myosmart trial kit myosmart.cuff 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 Ring MovoHook 2Grip Hook All Purpose Hook - VO Juvenile Hook - VO Dorso Arexa, Hyperextension orthosis 3D L.A.S.A.R. Posture Wrist Splint Manu Immobil Manu Immobil Long Wristorthosis Manu Neurexa, Plus Hand night splint for 28P30 Smartspine SI Support Extension Orthosis Postural Extension Cyberspine TLSOx4 Ottobock TLSO Dosi EQ Smartspine Extension Brace Cybercross TLSO Technogel Heel Pad VARIOUS MODELS (MULTIPLE) Bone Spur Pad Technogel - Full Insole Technogel - Heel Pad W. Soft Spot Connector for Hook Attachment Plate with Stud Adapter with Internal Thread Connector Otto Bock System Hand -voluntary opening Otto Bock System Hand -passive- Hand Adaptor MyoWrist Physolino Babyhand Attachment Plate with short stud Adapter MyolinoWrist 2000 Wrist Connector of wood Below-Elbow Harness Connection Piece for Hook Otto Bock System Hand -voluntary closing O.B. Disconnect Adaptor Modular Adapter for Arm Liners Modular Wrist Unit MovoWrist Flex Triple-Control Above-Elbow Harness MyoRotronic AxonRotation Electric Wrist Rotator 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 Bionic Pro AxonHook Herniaplast EQ Basis Stutzy EQ Abdo Low Herniaplast EQ Scrotum Suspender Herniaplast EQ Classic Kapok for Hernia Supports Suspensoir Stutzy EQ Abdo High Stutzy EQ 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 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 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 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 Omo Immobil Sling , abduction QuickValve Omo Immobil Sling Shoulder Orthosis Omo Immobil Omo Immobil Rotation Plastic Suspension Strap Modified Silesian Bandage 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 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 Cosa Active Starterkit Hip Joint for Children Textile Cover Splint Hip Joint for Derotat.Orthotics Lorracher Hip Abduct. Splint Lumbal Pelotte Kit for Lumbo Carezza, Direxa Syst.Free Motion Hip Joint Tubinger Hip Flexion Orthosis Hip Joint Hip Abduction Orthosis Cosa Junior Starterkit Transhumeral Soft Harness 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 PRN Original Elbow Pad RX Elbow Sleeve X-RX Wrist Support X-RX Elbow Support RX Original Elbow Sleeve UD Tennis Elbow Sleeve Arm Abduction Orthosis Acro Assist UD Tennis Elbow Strap UD Hyper-X Elbow Brace QD Forearm Sleeve 1,5mm Pair Black PRN Elbow Pad QD Elbow Sleeve PRN Elbow Pad Jr Arm Abduction Orthosis, Dynamic QD Wrist & Thumb Support QD Shoulder Support UD X-Stable Shoulder Brace PRN Original Elbow Pad Jr Nexgear Free Knee Lamination lancet UL Joint Nexgear Lock Knee Extension wedge set for 17KF210=*-10-*-* System-Full-Stirrup System Side Bar Set Split Stirrup Pelvic Band System-Split Stirrup System Stirrup, forked Framework for DTO CarbonIQ System Knee Joint , Aqualine orthotic knee joint Unilateral Knee Joint System-Verlangerungsteile-Satz System Lamin. Joint Bar w.Contoured Calf System-Side Bar Set-Alum. Foot Stirrup, stainless steel Power unit for correction joints System Shoe Stirrup, Double Sided C-Brace medial follower Nexgear Posterior Knee Ankle Joint Bar C-Brace unilateral adapter plate System Lamination Joint Bar Syst. Ring Lock Joint Head Aqualine Ankle Joint Extension wedge set for 17KF210 System-Full Stirrup System-Side Bar Set-S.S. Medial Follower System-Caliper Plate Unilateral ankle joint C-Brace Symphysis support 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. 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 Myo Plus trial kit Myo Plus Myo Plus TR Remote Electrode Myo Cuff Monozentric Hip-Joint with hydraulic control mode Modular Hip Joint-Child Modular hip joint Modular Single Axis Hip Joint Helix3D Hip joint Modular Hip Joint -Free Motion- 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 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

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer)