FDA Registration
Active
🇨🇦 Canada
OTTO BOCK HEALTHCARE CANADA
Reg #: 1000228440
·
FEI: 1000228440
·
Expires 2026
Products
12
Proprietary Names
395
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- OTTO BOCK HEALTHCARE CANADA
- Registration Number
- 1000228440
- FEI Number
- 1000228440
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5470 HARVESTER ROAD
- City
- BURLINGTON Ontario
- Country
- CA
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
- [email protected]
- Phone
- 801 9746647
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 2005-07-28 |
| Joint, Hip, External Limb Component | ISL | Class 1 | Physical Medicine | No | 2005-05-12 |
| Joint, Knee, External Limb Component | ISY | Class 1 | Physical Medicine | No | 2005-07-28 |
| Joint, Elbow, External Limb Component, Powered | IRE | Class 1 | Physical Medicine | No | 2005-09-26 |
| Hand, External Limb Component, Mechanical | IRA | Class 1 | Physical Medicine | No | 2014-11-03 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2014-08-04 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2005-07-28 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2005-09-26 |
| Adaptor, Recreational | ILT | Class 1 | Physical Medicine | No | 2016-11-01 |
| Prosthesis, Thigh Socket, External Component | ISS | Class 1 | Physical Medicine | No | 2005-05-12 |
| Unit, Wrist, External Limb Component, Powered | KGH | Class 1 | Physical Medicine | No | 2005-09-26 |
| Joint, Shoulder, External Limb Component | IQQ | Class 1 | Physical Medicine | No | 2005-05-12 |
Proprietary Names
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
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-
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
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
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
Smartspine SI Support
Extension Orthosis
Postural Extension
Cyberspine TLSOx4
Ottobock TLSO
Dosi EQ
Smartspine Extension Brace
Cybercross TLSO
VARIOUS MODELS (MULTIPLE)
Flip2Sit
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
MyoRotronic
AxonRotation
Electric Wrist Rotator
MovoShoulder Swing
Otto Bock Shoulder Joint
Otto Bock Ball Shoulder Joint
Establishment Types
Manufacture Medical Device