COMFORT ELECTRIC SCOOTER, LY-EW408


Device Classification Name

vehicle, motorized 3-wheeled

510(k) Number K072712
Device Name COMFORT ELECTRIC SCOOTER, LY-EW408
Applicant
COMFORT ORTHOPEDIC CO. LTD.
no 58 fu-chiun st.
hsin-chu city, 

TW

Applicant Contact ke-min jen
Correspondent
COMFORT ORTHOPEDIC CO. LTD.
no 58 fu-chiun st.
hsin-chu city, 

TW

Correspodent Contact ke-min jen
Regulation Number 890.3800
Classification Product Code
INI  
Date Received 09/25/2007
Decision Date 10/31/2007
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