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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Cervical-Thoracic, Rigid | IQF | Class 1 | Physical Medicine | No | 2018-04-09 |
| Prosthesis, Thigh Socket, External Component | ISS | Class 1 | Physical Medicine | No | 2005-05-12 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2005-07-28 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2005-09-26 |
| Orthosis, Cranial | MVA | Class 2 | Neurology | No | 2021-03-26 |
| Orthosis, Cranial, Laser Scan | OAN | Class 2 | Neurology | No | 2021-03-26 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2005-07-28 |
| Assembly, Knee/Shank/Ankle/Foot, External | ISW | Class 2 | Physical Medicine | No | 2004-12-29 |
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 2005-07-28 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2005-07-28 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2005-07-28 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2005-07-28 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2014-08-04 |
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