FDA Registration Active 🇺🇸 United States

OTTO BOCK HEALTHCARE LP

Reg #: 1721652 · FEI: 1721652 · Expires 2026
Products
13
Proprietary Names
407
Establishment Types
4
Classifications
13

Registration Details

Registration Name
OTTO BOCK HEALTHCARE LP
Registration Number
1721652
FEI Number
1721652
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
3820 West Great Lakes Drive
City
Salt Lake City
State
UT
ZIP
84120
Country
US

Regulatory Submissions

510(k) Number
K201426

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

Products

Device Name Product Code
Orthosis, Cervical-Thoracic, Rigid IQF
Prosthesis, Thigh Socket, External Component ISS
Orthosis, Lumbar IQE
Orthosis, Limb Brace IQI
Orthosis, Cranial MVA
Orthosis, Cranial, Laser Scan OAN
Orthosis, Lumbo-Sacral IPY
Assembly, Knee/Shank/Ankle/Foot, External ISW
Component, External, Limb, Ankle/Foot ISH
Joint, Ankle, External Brace ITW
Orthosis, Thoracic IPT
Orthosis, Cervical IQK
Cover, Limb IPM

Proprietary Names

CTO Cervicle Thoracic Orthosis 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 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 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 MyCRO Band 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 Empower 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 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 Smartspine SI Support Extension Orthosis Postural Extension Cyberspine TLSOx4 Ottobock TLSO Dosi EQ Smartspine Extension Brace Cybercross TLSO Mini Minerva Orthosis Cervical Immobilizer Necky Color Forte Cervical Orthoses Cyberspine Cervical Orthosis Smartspine Universal Collar Minerva Necky Color Cervical Orthoses 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

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Repack or Relabel Medical Device