Company ยท US
Otto Bock Healthcare LP
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2022. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 9, 2022 | K213587 | MyCRO Band Otto Bock Healthcare LP | MVA |
| Mar 26, 2021 | K201426 | MyCRO Band Otto Bock Healthcare LP | MVA |
| Mar 11, 2013 | K113164 | DISCOVERY TMAX MANUAL WHEELCHAIR Otto Bock Healthcare LP | IOR |
| Sep 16, 2011 | K111278 | Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE Otto Bock Healthcare LP | ITI |
| Jul 15, 2011 | K111045 | CENTRO FAMILY OF MANUAL WHEELCHAIRS Otto Bock Healthcare LP | IOR |
| Sep 29, 2010 | K101524 | C2000 POWERED WHEELCHAIR Otto Bock Healthcare LP | ITI |
| Oct 28, 2008 | K082314 | BRAVORACER PEDIATRIC MANUAL WHEELCHAIR Otto Bock Healthcare LP | IOR |
| Jan 14, 2008 | K073512 | START JUNIOR Otto Bock Healthcare LP | IOR |
| May 11, 2007 | K070318 | SKIPPI POWERED WHEELCHAIR FOR CHILDREN Otto Bock Healthcare LP | ITI |
| May 3, 2006 | K052771 | SENSOR WALK Otto Bock Healthcare LP | IQI |
| Dec 27, 2005 | K052706 | A-200 POWERED WHEELCHAIR Otto Bock Healthcare LP | ITI |
| Oct 6, 2005 | K052681 | START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI) Otto Bock Healthcare LP | IOR |
| Oct 1, 2004 | K041211 | POWERED WHEELCHAIR, MODEL C-1000 Otto Bock Healthcare LP | ITI |
| Oct 1, 2004 | K041210 | POWERED WHEELCHAIR, MODEL B-600 Otto Bock Healthcare LP | ITI |
| Oct 1, 2004 | K041208 | POWERED WHEELCHAIR, MODEL B-500 Otto Bock Healthcare LP | ITI |
| Sep 9, 2004 | K041215 | CRANIAL HELMET Otto Bock Healthcare LP | MVA |
| Sep 23, 2003 | K032833 | MYOSYSTEM WITH CUSTOMIZING Otto Bock Healthcare LP | GXY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2016 | Otto Bock Healthcare GmbH Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb. Terminated |
ISY | None listed |
| Nov 4, 2015 | Otto Bock Healthcare GmbH iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot. Terminated |
ISH | None listed |
| Jul 24, 2015 | Otto Bock Healthcare GmbH 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 attach Terminated |
ISY | None listed |