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

FDA Device Registration & Listing · DUDERSTADT Lower Saxony, DE · Registration 9616494

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
9616494
FEI Number
3003117657
Entity Name
Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH
City/State/Country
DUDERSTADT Lower Saxony, DE
Establishment Address
Max-Naeder-Strasse 15, DUDERSTADT Lower Saxony D-37115, DE
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

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 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 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 Forearm Crutches

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ISP Valve, Prosthesis Physical Medicine Class 1 890.3420 2014-11-03
IRD Joint, Elbow, External Limb Component, Mechanical Physical Medicine Class 1 890.3420 2004-12-29
IPS Cane Physical Medicine Class 1 890.3075 1996-03-18
IQQ Joint, Shoulder, External Limb Component Physical Medicine Class 1 890.3420 2005-05-12
IPY Orthosis, Lumbo-Sacral Physical Medicine Class 1 890.3490 2005-07-28
IQK Orthosis, Cervical Physical Medicine Class 1 890.3490 2005-07-28
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
IQZ Hand, External Limb Component, Powered Physical Medicine Class 1 890.3420 2005-09-26
IQX Hook, External Limb Component, Mechanical Physical Medicine Class 1 890.3420 2014-11-03
MRI Orthosis, Truncal/Orthosis, Limb Physical Medicine Class 1 890.3490 2005-07-28
KHX Platform, Force-Measuring Physical Medicine Class 1 890.1575 2017-07-04
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2014-05-05
IPT Orthosis, Thoracic Physical Medicine Class 1 890.3490 2005-07-28
KNP Orthosis, Corrective Shoe Physical Medicine Class 1 890.3475 2005-07-28
IRA Hand, External Limb Component, Mechanical Physical Medicine Class 1 890.3420 2014-11-03
KGH Unit, Wrist, External Limb Component, Powered Physical Medicine Class 1 890.3420 2005-09-26
ISZ Unit, Wrist, External Limb Component, Mechanical Physical Medicine Class 1 890.3420 2012-09-13
KQX Goniometer, Ac-Powered Orthopedic Class 1 888.1500 2020-06-04
IQW Hook, External Limb Component, Powered Physical Medicine Class 1 890.3420 2016-07-05
EXN Support, Hernia Gastroenterology, Urology Class 1 876.5970 2016-09-22
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
IPM Cover, Limb Physical Medicine Class 1 890.3025 2014-08-04
IQO Device, Prosthesis Alignment Physical Medicine Class 1 890.3025 2014-11-03
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 2005-07-28
ILE Sling, Arm, Overhead Supported Physical Medicine Class 1 890.3475 2014-11-03
ISR Band Or Belt, Pelvic Support Physical Medicine Class 1 890.3025 2014-11-03
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2005-09-26
ISS Prosthesis, Thigh Socket, External Component Physical Medicine Class 1 890.3420 2005-05-12
IPR Crutch Physical Medicine Class 1 890.3150 1996-03-18

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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0006-2025 Ossur H F Grjothals 5 Reykjavik Iceland 1
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616494. Last updated year: 2026. Please use registration number 9616494 when referencing this establishment in official correspondence.
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