CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR


Device Classification Name

wheelchair, powered

510(k) Number K080385
Device Name CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR
Applicant
E1 ENT., INC.
1290 s.w. 30th ave.
pompano beach, 
FL 
33069

Applicant Contact jack cheng
Correspondent
E1 ENT., INC.
1290 s.w. 30th ave.
pompano beach, 
FL 
33069

Correspodent Contact jack cheng
Regulation Number 890.3860
Classification Product Code
ITI  
Date Received 02/13/2008
Decision Date 05/13/2008
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