Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE


Device Classification Name

wheelchair, powered

510(k) Number K111278
Device Name Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE
Applicant
OTTO BOCK HEALTHCARE, LP
two carlson parkway north
suite 100
minneapolis, 
MN 
55447 -4467

Applicant Contact william kabitz
Correspondent
OTTO BOCK HEALTHCARE, LP
two carlson parkway north
suite 100
minneapolis, 
MN 
55447 -4467

Correspodent Contact william kabitz
Regulation Number 890.3860
Classification Product Code
ITI  
Date Received 05/05/2011
Decision Date 09/16/2011
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