COMFORT AGILE SCOOTER, LY-EW303


Device Classification Name

vehicle, motorized 3-wheeled

510(k) Number K023581
Device Name COMFORT AGILE SCOOTER, LY-EW303
Original Applicant
COMFORT ORTHOPEDIC CO. LTD.
no 58 fu-chiun st.
hsin-chu city, 

TW

Original Contact jen ke-min
Regulation Number 890.3800
Classification Product Code
INI  
Date Received 10/24/2002
Decision Date 12/02/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No