510(k) K052771

SENSOR WALK by Otto Bock Healthcare LP — Product Code IQI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2006
Date Received
September 30, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Limb Brace
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type