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510(k) K032833

MYOSYSTEM WITH CUSTOMIZING by Otto Bock Healthcare LP — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2003
Date Received
September 11, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

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  • K111278 — Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE (September 16, 2011)
  • K111045 — CENTRO FAMILY OF MANUAL WHEELCHAIRS (July 15, 2011)
  • K101524 — C2000 POWERED WHEELCHAIR (September 29, 2010)
  • K082314 — BRAVORACER PEDIATRIC MANUAL WHEELCHAIR (October 28, 2008)
  • K073512 — START JUNIOR (January 14, 2008)
  • K070318 — SKIPPI POWERED WHEELCHAIR FOR CHILDREN (May 11, 2007)
  • K052771 — SENSOR WALK (May 3, 2006)

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  • K241160 — CAIs Sensor (CAIs-001) (December 13, 2024)
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