Otto Bock Healthcare Products GmbH

FDA Device Registration & Listing · Vienna Wien, AT · Registration 3005190268

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005190268
FEI Number
3005190268
Entity Name
Otto Bock Healthcare Products GmbH
City/State/Country
Vienna Wien, AT
Establishment Address
Brehmstrasse 16, Vienna Wien A-1110, AT
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Ottobock SE & Co. KGaA (Owner Number: 8010097)
Owner / Operator Contact Address
Max-Naeder-Strasse 15, Duderstadt, DE-NI 37115, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 Tube Valve for Suction Socket Axon-Bus Prosthetic System Service, Test AxonRotation AxonRotation Adapter Suction Socket Electrode AxonHook 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IRE Joint, Elbow, External Limb Component, Powered Physical Medicine Class 1 890.3420 2005-09-26
KGH Unit, Wrist, External Limb Component, Powered Physical Medicine Class 1 890.3420 2005-09-26
IQW Hook, External Limb Component, Powered Physical Medicine Class 1 890.3420 2016-07-05
ISP Valve, Prosthesis Physical Medicine Class 1 890.3420 2014-11-03
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2005-09-26
ISZ Unit, Wrist, External Limb Component, Mechanical Physical Medicine Class 1 890.3420 2012-09-13
IPM Cover, Limb Physical Medicine Class 1 890.3025 2014-08-04
ISH Component, External, Limb, Ankle/Foot Physical Medicine Class 1 890.3420 2005-07-28
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2014-08-06
IQZ Hand, External Limb Component, Powered Physical Medicine Class 1 890.3420 2014-08-06
IRD Joint, Elbow, External Limb Component, Mechanical Physical Medicine Class 1 890.3420 2004-12-29
IQZ Hand, External Limb Component, Powered Physical Medicine Class 1 890.3420 2026-04-24
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2026-04-24
IQO Device, Prosthesis Alignment Physical Medicine Class 1 890.3025 2014-11-03
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2014-05-05
IQZ Hand, External Limb Component, Powered Physical Medicine Class 1 890.3420 2005-09-26

Official Correspondent

No official correspondent registered.

US Agent Details

Caleb Beck Business: Otto Bock HealthCare LP Email: Caleb.Beck@ottobock.com Phone: (801) 9746647

Related Public Records

Same Entity

Ottobock SE & Co. KGaA
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007923118 Otto Bock Mobility Solutions GmbH Koenigsee Thuringia, DE
9681725 Otto Bock Manufacturing Konigsee GmbH Koenigsee Thuringia, DE
3001917653 OTTO BOCK ITALIA SRL BUDRIO Bologna, IT
9611742 OTTO BOCK (CHINA) INDUSTRIES CO., LTD. BEIJING, CN
3018070833 Ottobock Manufacturing Bulgaria EOOD Blagoevgrad, BG

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K070612 Top-Rank Health Care Equipment Co., Ltd. TOP-RANK ADHESIVE ELECTRODE 2007-05-07
K123915 Grass Technologies, an Astro-Med, Inc. Product Gro DE48-PLUS 2013-04-24
K073532 Technomed Europe DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES 2008-05-01
K260363 Ceribell, Inc. Ceribell Brain Monitor Headband 2026-04-03
K091762 Covidien DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE 2009-12-22

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005190268. Last updated year: 2026. Please use registration number 3005190268 when referencing this establishment in official correspondence.
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