ICON ADULT MANUAL


Device Classification Name

wheelchair, mechanical

510(k) Number K110985
Device Name ICON ADULT MANUAL
Applicant
ICON WHEELCHAIRS INC
115 bridge street
northampton, 
MA 
01060

Applicant Contact tom horton
Regulation Number 890.3850
Classification Product Code
IOR  
Date Received 04/08/2011
Decision Date 05/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No