LOTUS BLAKE ESTEEM SCOOTER


Device Classification Name

vehicle, motorized 3-wheeled

510(k) Number K103771
Device Name LOTUS BLAKE ESTEEM SCOOTER
Applicant
LETRIX POWER HANGZHOU PTY LTD
10352 stanford rd
garden grove, 
CA 
92840

Applicant Contact robert dunn
Correspondent
LETRIX POWER HANGZHOU PTY LTD
10352 stanford rd
garden grove, 
CA 
92840

Correspodent Contact robert dunn
Regulation Number 890.3800
Classification Product Code
INI  
Date Received 12/27/2010
Decision Date 05/06/2011
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