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Otto Bock Healthcare GmbH

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
17
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0608-2016Class IIOttobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetiJanuary 4, 2016
Z-0209-2016Class IIiOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton SmaOctober 23, 2015
Z-2261-2015Class IIOttobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to July 16, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K213587MyCRO BandJune 9, 2022
K201426MyCRO BandMarch 26, 2021
K113164DISCOVERY TMAX MANUAL WHEELCHAIRMarch 11, 2013
K111278Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICESeptember 16, 2011
K111045CENTRO FAMILY OF MANUAL WHEELCHAIRSJuly 15, 2011
K101524C2000 POWERED WHEELCHAIRSeptember 29, 2010
K082314BRAVORACER PEDIATRIC MANUAL WHEELCHAIROctober 28, 2008
K073512START JUNIORJanuary 14, 2008
K070318SKIPPI POWERED WHEELCHAIR FOR CHILDRENMay 11, 2007
K052771SENSOR WALKMay 3, 2006
K052706A-200 POWERED WHEELCHAIRDecember 27, 2005
K052681START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI)October 6, 2005
K041208POWERED WHEELCHAIR, MODEL B-500October 1, 2004
K041211POWERED WHEELCHAIR, MODEL C-1000October 1, 2004
K041210POWERED WHEELCHAIR, MODEL B-600October 1, 2004
K041215CRANIAL HELMETSeptember 9, 2004
K032833MYOSYSTEM WITH CUSTOMIZINGSeptember 23, 2003