Medical Device Manufacturer · US , Minneapolis , MN

Otto Bock Healthcare LP - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 2003
17
Total
17
Cleared
0
Denied

Otto Bock Healthcare LP has 17 FDA 510(k) cleared physical medicine devices. Based in Minneapolis, US.

Last cleared in 2022. Active since 2003.

Browse the complete list of FDA 510(k) cleared physical medicine devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Strategic Quality Solutions, LLC as regulatory consultant.

FDA 510(k) Regulatory Record - Otto Bock Healthcare LP

17 devices
1-17 of 17
Cleared Jun 09, 2022
MyCRO Band
K213587 · MVA
Neurology · 209d
Cleared Mar 26, 2021
MyCRO Band
K201426 · MVA
Neurology · 301d
Cleared Mar 11, 2013
DISCOVERY TMAX MANUAL WHEELCHAIR
K113164 · IOR
Physical Medicine · 502d
Cleared Sep 16, 2011
Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE
K111278 · ITI
Physical Medicine · 134d
Cleared Jul 15, 2011
CENTRO FAMILY OF MANUAL WHEELCHAIRS
K111045 · IOR
Physical Medicine · 91d
Cleared Sep 29, 2010
C2000 POWERED WHEELCHAIR
K101524 · ITI
Physical Medicine · 119d
Cleared Oct 28, 2008
BRAVORACER PEDIATRIC MANUAL WHEELCHAIR
K082314 · IOR
Physical Medicine · 76d
Cleared Jan 14, 2008
START JUNIOR
K073512 · IOR
Physical Medicine · 31d
Cleared May 11, 2007
SKIPPI POWERED WHEELCHAIR FOR CHILDREN
K070318 · ITI
Physical Medicine · 98d
Cleared May 03, 2006
SENSOR WALK
K052771 · IQI
Physical Medicine · 215d
Cleared Dec 27, 2005
A-200 POWERED WHEELCHAIR
K052706 · ITI
Physical Medicine · 90d
Cleared Oct 06, 2005
START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI)
K052681 · IOR
Physical Medicine · 8d
Cleared Oct 01, 2004
POWERED WHEELCHAIR, MODEL B-500
K041208 · ITI
Physical Medicine · 144d
Cleared Oct 01, 2004
POWERED WHEELCHAIR, MODEL B-600
K041210 · ITI
Physical Medicine · 144d
Cleared Oct 01, 2004
POWERED WHEELCHAIR, MODEL C-1000
K041211 · ITI
Physical Medicine · 144d
Cleared Sep 09, 2004
CRANIAL HELMET
K041215 · MVA
Neurology · 122d
Cleared Sep 23, 2003
MYOSYSTEM WITH CUSTOMIZING
K032833 · GXY
Neurology · 12d
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