OPTI-RIDER DELUXE


Device Classification Name

vehicle, motorized 3-wheeled

510(k) Number K033116
Device Name OPTI-RIDER DELUXE
Applicant
HANSUNG ECONET CO., LTD.
49 plain street
north attleboro, 
MA 
02760

Applicant Contact cynthia j.m. nolte
Correspondent
HANSUNG ECONET CO., LTD.
49 plain street
north attleboro, 
MA 
02760

Correspodent Contact cynthia j.m. nolte
Regulation Number 890.3800
Classification Product Code
INI  
Date Received 09/30/2003
Decision Date 04/12/2004
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