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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K080950
Device Name STIWELL MED4
Applicant
Otto Bock, Austria GmbH
2247 Jennifer Ln.
St Paul,  MN  55109
Applicant Contact WILLIAM F JACKSON
Correspondent
Otto Bock, Austria GmbH
2247 Jennifer Ln.
St Paul,  MN  55109
Correspondent Contact WILLIAM F JACKSON
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZI   GZJ   HCC   KPI  
Date Received04/03/2008
Decision Date 04/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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