Otto Bock Healthcare LP
Salt Lake City, UT, US
OTTO BOCK HEALTHCARE LP appears in FDA device records in Salt Lake City, UT. FDA records list 17 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Otto Bock Healthcare LP carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbHregistration
510(k) clearance history
FDA records hold 17 510(k) clearances for Otto Bock Healthcare LP between 2003 and 2022. The busiest year on record is 2004, with 4. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 4 |
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 2 |
| 2010 | 1 |
| 2011 | 2 |
| 2013 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213587 | MyCRO Band | MVA | Substantially Equivalent | |
| K201426 | MyCRO Band | MVA | Substantially Equivalent | |
| K113164 | DISCOVERY TMAX MANUAL WHEELCHAIR | IOR | Substantially Equivalent | |
| K111278 | Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE | ITI | Substantially Equivalent | |
| K111045 | CENTRO FAMILY OF MANUAL WHEELCHAIRS | IOR | Substantially Equivalent | |
| K101524 | C2000 POWERED WHEELCHAIR | ITI | Substantially Equivalent | |
| K082314 | BRAVORACER PEDIATRIC MANUAL WHEELCHAIR | IOR | Substantially Equivalent | |
| K073512 | START JUNIOR | IOR | Substantially Equivalent | |
| K070318 | SKIPPI POWERED WHEELCHAIR FOR CHILDREN | ITI | Substantially Equivalent | |
| K052771 | SENSOR WALK | IQI | Substantially Equivalent | |
| K052706 | A-200 POWERED WHEELCHAIR | ITI | Substantially Equivalent | |
| K052681 | START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI) | IOR | Substantially Equivalent | |
| K041211 | POWERED WHEELCHAIR, MODEL C-1000 | ITI | Substantially Equivalent | |
| K041210 | POWERED WHEELCHAIR, MODEL B-600 | ITI | Substantially Equivalent | |
| K041208 | POWERED WHEELCHAIR, MODEL B-500 | ITI | Substantially Equivalent | |
| K041215 | CRANIAL HELMET | MVA | Substantially Equivalent | |
| K032833 | MYOSYSTEM WITH CUSTOMIZING | GXY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1721652 | 1721652 | OTTO BOCK HEALTHCARE LP | 3820 West Great Lakes Drive, Salt Lake City, UT 84120 US | 2026 | and 3 more, listed in full below |
| 3010822759 | 3010822759 | Otto Bock Healthcare LP | 521 Industry Road Distribution Center, Louisville, KY 40208 US | 2026 | No device listings on this registration |
| 9616494 | 3003117657 | Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH | Max-Naeder-Strasse 15, DUDERSTADT Lower Saxony D-37115 DE | 2026 | and 29 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- ISWAssembly, Knee/Shank/Ankle/Foot, External
- ISRBand Or Belt, Pelvic Support
- ITGBandage, Cast
- IPSCane
- ISHComponent, External, Limb, Ankle/Foot
- IPMCover, Limb
- IPRCrutch
- IQODevice, Prosthesis Alignment
- GXYElectrode, Cutaneous
- KQXGoniometer, Ac-Powered
- IRAHand, External Limb Component, Mechanical
- IQZHand, External Limb Component, Powered
- IQXHook, External Limb Component, Mechanical
- IQWHook, External Limb Component, Powered
- ITWJoint, Ankle, External Brace
- IRDJoint, Elbow, External Limb Component, Mechanical
- IREJoint, Elbow, External Limb Component, Powered
- ITSJoint, Hip, External Brace
- ISLJoint, Hip, External Limb Component
- ITQJoint, Knee, External Brace
- ISYJoint, Knee, External Limb Component
- IQQJoint, Shoulder, External Limb Component
- IQKOrthosis, Cervical
- IQFOrthosis, Cervical-Thoracic, Rigid
- KNPOrthosis, Corrective Shoe
- MVAOrthosis, Cranial
- OANOrthosis, Cranial, Laser Scan
- IQIOrthosis, Limb Brace
- IQEOrthosis, Lumbar
- IPYOrthosis, Lumbo-Sacral
- IPWOrthosis, Sacroiliac, Soft
- IPTOrthosis, Thoracic
- MRIOrthosis, Truncal/Orthosis, Limb
- KHXPlatform, Force-Measuring
- ISSProsthesis, Thigh Socket, External Component
- ILESling, Arm, Overhead Supported
- ILHSplint, Hand, And Components
- ITCStirrup, External Brace Component
- IOYSupport, Arm
- EXNSupport, Hernia
- ISZUnit, Wrist, External Limb Component, Mechanical
- KGHUnit, Wrist, External Limb Component, Powered
- ISPValve, Prosthesis
- IORWheelchair, Mechanical
- ITIWheelchair, Powered
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0608-2016 | Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb. | Otto Bock HealthCare GmbH is recalling Modular Polycentric EBS Knee Joint that were serviced between 27 April 2015 and 17 November 2015 due to a service error where the wrong Loctite was used during repair. | Class II | Terminated | |
| Z-0209-2016 | iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot. | A software issue can make the foot move into dorsiflexion, unnoticed by the user, who could fall. When sitting, the prosthetic foot can go into the Relief Function to move the footplate towards the ground. When operating machines with foot pedals (e.g. a car) the foot could get stuck under the foot pedal and block it or, with the foot on the pedal, it could cause unintended vehicle acceleration. | Class II | Terminated | |
| Z-2261-2015 | Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology. | Otto Bock Healthcare GmbH is voluntarily recalling all 3R62 Pheon polycentric prosthetic knee joints distributed since February 2014 because the locking function may fail under certain conditions which may result in a fall. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Otto Bock Healthcare LP edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain