STIWELL MED4


Device Classification Name

stimulator, muscle, powered

510(k) Number K080950
Device Name STIWELL MED4
Applicant
OTTO BOCK, AUSTRIA GMBH
2247 jennifer lane
north st. paul, 
MN 
55109 -2851

Applicant Contact william f jackson
Correspondent
OTTO BOCK, AUSTRIA GMBH
2247 jennifer lane
north st. paul, 
MN 
55109 -2851

Correspodent Contact william f jackson
Regulation Number 890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZI   GZJ   HCC   KPI  
Date Received 04/03/2008
Decision Date 04/02/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No